FDA Enforcement Class II Terminated

Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE.

Recall: Z-0411-2019 · Reported November 21, 2018

Enforcement

Recall Number
Z-0411-2019
Event ID
81182
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
GE Healthcare, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
November 21, 2018
Initiation Date
September 27, 2018
Classification Date
November 9, 2018
Termination Date
April 12, 2021
Address
3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

Description

Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE.

Reason

Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.

Code Info

Model Number, UDI Number, (Serial Number): 2097674-001-US, Not Applicable, (5470345-30); 2097674-001-US, Not Applicable, (5470345-31); 2097674-001-US, Not Applicable, (5470345-32); 1011-9000-000, Not Applicable, (ANAK00774); 1011-9000-000, Not Applicable, (ANAK00775); 1011-9000-000, Not Applicable, (ANAL01201); 1011-9000-000, Not Applicable, (ANAL01234); 1011-9000-000, Not Applicable, (ANAL01235); 1011-9000-000, Not Applicable, (ANAL01236); 1011-9000-000, Not Applicable, (ANAL01237); 1011-9000-000, Not Applicable, (ANAL01238); 1011-9000-000, Not Applicable, (ANAL01240); 1011-9000-000, Not Applicable, (ANAL01494); 1011-9000-000, Not Applicable, (ANAL01495); 1011-9000-000, Not Applicable, (ANAL01551); 1011-9000-000, Not Applicable, (ANAM01023); 1011-9000-000, Not Applicable, (ANAM01024); 1011-9000-000, Not Applicable, (ANAM01025); 1011-9000-000, Not Applicable, (ANAM01026); 1011-9000-000, Not Applicable, (ANAM01027); 1011-9000-000, Not Applicable, (ANAM01104); 1011-9000-000, Not Applicable, (ANAM01105); 1011-9000-000, Not Applicable, (ANAP00438); 1011-9000-000, Not Applicable, (ANAP00439); 1011-9000-000, Not Applicable, (ANAQ01188); 1011-9000-000, Not Applicable, (ANAR05264); 1011-9000-000, Not Applicable, (ANAR05265); 1011-9000-000, Not Applicable, (ANAR05610); 1011-9000-000, Not Applicable, (ANAR05611); 1011-9000-000, Not Applicable, (ANAS00202); 1011-9000-000, Not Applicable, (ANAS00203); 1011-9000-000, Not Applicable, (ANAS00204); 2097674-001-US, Not Applicable, (5479630-1); ANAK00798, Not Applicable (1011-9000-000); ANAK00799, Not Applicable (1011-9000-000); ANAK00803, Not Applicable (1011-9000-000); ANAK00807, Not Applicable (1011-9000-000); ANAK00814, Not Applicable (1011-9000-000); ANAK00839, Not Applicable (1011-9000-000); ANAK00864, Not Applicable (1011-9000-000); 5481223-1, Not Applicable (2097674-001-US); 5481223-10, Not Applicable (2097674-001-US); 5481223-11, Not Applicable (2097674-001-US); 5481223-12, Not Applicable (2097674-001-US); 5481223-2, Not Applicable (2097674-001-US); 5481223-3, Not Applicable (2097674-001-US); 5481223-4, Not Applicable (2097674-001-US); 5481223-5, Not Applicable (2097674-001-US); 5481223-6, Not Applicable (2097674-001-US); 5481223-7, Not Applicable (2097674-001-US); 5481223-8, Not Applicable (2097674-001-US); 5481223-9, Not Applicable (2097674-001-US); ANAP00712, Not Applicable (1011-9000-000); ANAP00713, Not Applicable (1011-9000-000); ANAP00714, Not Applicable (1011-9000-000); ANAN01125, Not Applicable (1011-9000-000); ANAN01138, Not Applicable (1011-9000-000); 4652664-1, Not Applicable (2097674-001-US); 4652664-10, Not Applicable (2097674-001-US); 4652664-11, Not Applicable (2097674-001-US); 4652664-12, Not Applicable (2097674-001-US); 4652664-13, Not Applicable (2097674-001-US); 4652664-2, Not Applicable (2097674-001-US); 4652664-3, Not Applicable (2097674-001-US); 4652664-4, Not Applicable (2097674-001-US); 4652664-5, Not Applicable (2097674-001-US); 4652664-6, Not Applicable (2097674-001-US); 4652664-7, Not Applicable (2097674-001-US); 4652664-8, Not Applicable (2097674-001-US); 4652664-9, Not Applicable (2097674-001-US); ANAK00156, Not Applicable (1011-9000-000); ANAK00157, Not Applicable (1011-9000-000); ANAK00158, Not Applicable (1011-9000-000); ANAK00159, Not Applicable (1011-9000-000); ANAK00511, Not Applicable (1011-9000-000); ANAK00512, Not Applicable (1011-9000-000); ANAK00513, Not Applicable (1011-9000-000); ANAK00514, Not Applicable (1011-9000-000); ANAN01051, Not Applicable (1011-9000-000); ANAN01052, Not Applicable (1011-9000-000); ANAP00545, Not Applicable (1011-9000-000); ANAP00546, Not Applicable (1011-9000-000); ANAP00708, Not Applicable (1011-9000-000); ANAL01400, Not Applicable (1011-9000-000); ANAL01401, Not Applicable (1011-9000-000); ANAM00449, Not Applicable (1011-9000-000); ANAM01089, Not Applicable (1011-9000-000); 5453450-1, Not Applicable (2097674-001); 5453450-2, Not Applicable (2097674-001); 5453450-3, Not Applicable (2097674-001); 5453450-4, Not Applicable (2097674-001); 5453450-5, Not Applicable (2097674-001); 5453450-6, Not Applicable (2097674-001); 5453450-7, Not Applicable (2097674-001); 5453450-8, Not Applicable (2097674-001); 5480532-1, Not Applicable (2097674-001); 5447751-1, Not Applicable (2097674-001); 5447751-10, Not Applicable (2097674-001); 5447751-11, Not Applicable (2097674-001); 5447751-12, Not Applicable (2097674-001); 5447751-13, Not Applicable (2097674-001); 5447751-14, Not Applicable (2097674-001); 5447751-15, Not Applicable (2097674-001); 5447751-16, Not Applicable (2097674-001); 5447751-17, Not Applicable (2097674-001); 5447751-18, Not Applicable (2097674-001); 5447751-19, Not Applicable (2097674-001); 5447751-2, Not Applicable (2097674-001); 5447751-20, Not Applicable (2097674-001); 5447751-21, Not Applicable (2097674-001); 5447751-22, Not Applicable (2097674-001); 5447751-23, Not Applicable (2097674-001); 5447751-24, Not Applicable (2097674-001); 5447751-3, Not Applicable (2097674-001); 5447751-4, Not Applicable (2097674-001); 5447751-5, Not Applicable (2097674-001); 5447751-6, Not Applicable (2097674-001); 5447751-7, Not Applicable (2097674-001); 5447751-8, Not Applicable (2097674-001); 5447751-9, Not Applicable (2097674-001); 5452649-1, Not Applicable (2097674-001); 5452649-2, Not Applicable (2097674-001); 5474323-1, Not Applicable (2097674-DE); ANAR05021, Not Applicable (1011-9000-000); 5473625-5, Not Applicable (2097674-NL); 5473625-6, Not Applicable (2097674-NL); 5473625-7, Not Applicable (2097674-NL); ANAK00330, Not Applicable (1011-9000-000); ANAK00332, Not Applicable (1011-9000-000); ANAK00334, Not Applicable (1011-9000-000); ANAL00806, Not Applicable (1011-9000-000); ANAL00807, Not Applicable (1011-9000-000); ANAL00808, Not Applicable (1011-9000-000); ANAL00809, Not Applicable (1011-9000-000); ANAN01010, Not Applicable (1011-9000-000); ANAN01011, Not Applicable (1011-9000-000); ANAN01012, Not Applicable (1011-9000-000); ANAN01013, Not Applicable (1011-9000-000); ANAN01014, Not Applicable (1011-9000-000); ANAP00399, Not Applicable (1011-9000-000); ANAP01133, Not Applicable (1011-9000-000); ANAR00344, Not Applicable (1011-9000-000); ANAR00896, Not Applicable (1011-9000-000); ANAR05978, Not Applicable (1011-9000-000); ANAR05979, Not Applicable (1011-9000-000); ANAR05980, Not Applicable (1011-9000-000); ANAR05981, Not Applicable (1011-9000-000); ANAR05982, Not Applicable (1011-9000-000); ANAR05983, Not Applicable (1011-9000-000); ANAR05984, Not Applicable (1011-9000-000); ANAS00709, Not Applicable (1011-9000-000); ANAS00710, Not Applicable (1011-9000-000); ANAS00711, Not Applicable (1011-9000-000); 5472401-2, Not Applicable (2097674-001); ANAP00132, Not Applicable (1011-9000-000); 5472557-4, Not Applicable (2097674-001); 5472557-5, Not Applicable (2097674-001); 5472557-6, Not Applicable (2097674-001); ANAN01045, Not Applicable (1011-9000-000); ANAN01046, Not Applicable (1011-9000-000); ANAR00327, Not Applicable (1011-9000-000); ANAS00345, Not Applicable (1011-9000-000); 5454764-3, Not Applicable (2097674-001); ANAP00584, Not Applicable (1011-9000-000); ANAP00585, Not Applicable (1011-9000-000); ANAP00586, Not Applicable (1011-9000-000); ANAP00587, Not Applicable (1011-9000-000); ANAP00588, Not Applicable (1011-9000-000); ANAP00589, Not Applicable (1011-9000-000); ANAP00825, Not Applicable (1011-9000-000); ANAP01215, Not Applicable (1011-9000-000); ANAS00738, Not Applicable (1011-9000-000); ANAL01390, Not Applicable (1011-9000-000); ANAL01391, Not Applicable (1011-9000-000); ANAS00391, Not Applicable (1011-9000-000); ANAR00492, Not Applicable (1011-9000-000); ANAR00493, Not Applicable (1011-9000-000); ANAR00494, Not Applicable (1011-9000-000); ANAR00495, Not Applicable (1011-9000-000); ANAR00496, Not Applicable (1011-9000-000); ANAR00497, Not Applicable (1011-9000-000); ANAR00498, Not Applicable (1011-9000-000); ANAR00499, Not Applicable (1011-9000-000); ANAR00500, Not Applicable (1011-9000-000); ANAR00501, Not Applicable (1011-9000-000); ANAR00756, Not Applicable (1011-9000-000); ANAR00757, Not Applicable (1011-9000-000); ANAL00705, Not Applicable (1011-9000-000); ANAL01040, Not Applicable (1011-9000-000); ANAL01041, Not Applicable (1011-9000-000); ANAL01042, Not Applicable (1011-9000-000); ANAL01043, Not Applicable (1011-9000-000); ANAL01044, Not Applicable (1011-9000-000); ANAL01045, Not Applicable (1011-9000-000); ANAL01046, Not Applicable (1011-9000-000); ANAL01047, Not Applicable (1011-9000-000); ANAL01048, Not Applicable (1011-9000-000); ANAL01050, Not Applicable (1011-9000-000); ANAM00335, Not Applicable (1011-9000-000); ANAL00192, Not Applicable (1011-9000-000); ANAL00754, Not Applicable (1011-9000-000); ANAL00755, Not Applicable (1011-9000-000); ANAL00756, Not Applicable (1011-9000-000); ANAL00757, Not Applicable (1011-9000-000); ANAL00764, Not Applicable (1011-9000-000); ANAL00769, Not Applicable (1011-9000-000); ANAL00776, Not Applicable (1011-9000-000); ANAL00777, Not Applicable (1011-9000-000); ANAL00778, Not Applicable (1011-9000-000); ANAL00779, Not Applicable (1011-9000-000); ANAL00780, Not Applicable (1011-9000-000); ANAL00781, Not Applicable (1011-9000-000); ANAL00782, Not Applicable (1011-9000-000); ANAL00783, Not Applicable (1011-9000-000); ANAL00784, Not Applicable (1011-9000-000); ANAL00785, Not Applicable (1011-9000-000); ANAL00786, Not Applicable (1011-9000-000); ANAL00787, Not Applicable (1011-9000-000); ANAL00788, Not Applicable (1011-9000-000); ANAL00789, Not Applicable (1011-9000-000); ANAL00790, Not Applicable (1011-9000-000); ANAL00791, Not Applicable (1011-9000-000); ANAL00792, Not Applicable (1011-9000-000); ANAL01541, Not Applicable (1011-9000-000); ANAL01542, Not Applicable (1011-9000-000); ANAP00810, Not Applicable (1011-9000-000); ANAP00811, Not Applicable (1011-9000-000); ANAS00938, Not Applicable (1011-9000-000); ANAP01070, Not Applicable (1011-9000-000); 5473409-1, Not Applicable (2097674-FR); 5473409-2, Not Applicable (2097674-FR); 5473409-3, Not Applicable (2097674-FR); ANAP00517, Not Applicable (1011-9000-000); ANAP00518, Not Applicable (1011-9000-000); ANAP00519, Not Applicable (1011-9000-000); ANAM01291, Not Applicable (1011-9000-000); ANAM01292, Not Applicable (1011-9000-000); ANAM01293, Not Applicable (1011-9000-000); ANAN00430, Not Applicable (1011-9000-000); ANAN00431, Not Applicable (1011-9000-000); ANAN00432, Not Applicable (1011-9000-000); ANAN00436, Not Applicable (1011-9000-000); ANAN00437, Not Applicable (1011-9000-000); ANAP00300, Not Applicable (1011-9000-000); ANAQ00766, Not Applicable (1011-9000-000); ANAS00753, Not Applicable (1011-9000-000); ANAP00492, Not Applicable (1011-9000-000); ANAP00493, Not Applicable (1011-9000-000); ANAM00628, Not Applicable (1011-9000-000); ANAL01029, Not Applicable (1011-9000-000); 5479515-1, Not Applicable (2097674-JA); 5479515-2, Not Applicable (2097674-JA); 5479515-3, Not Applicable (2097674-JA); 5479515-4, Not Applicable (2097674-JA); 5479515-5, Not Applicable (2097674-JA); 5479515-6, Not Applicable (2097674-JA); 5479515-7, Not Applicable (2097674-JA); 5479515-8, Not Applicable (2097674-JA); 5479515-9, Not Applicable (2097674-JA); 5480673-1, Not Applicable (2097674-JA); 5480673-2, Not Applicable (2097674-JA); 5480673-3, Not Applicable (2097674-JA); 5480673-4, Not Applicable (2097674-JA); 5480673-5, Not Applicable (2097674-JA); 5480673-6, Not Applicable (2097674-JA); 5480673-7, Not Applicable (2097674-JA); 5480673-8, Not Applicable (2097674-JA); 5483069-1, Not Applicable (2097674-JA); ANAQ01435, Not Applicable (1011-9000-000); ANAM01312, Not Applicable (1011-9000-000); ANAM01313, Not Applicable (1011-9000-000); ANAM01315, Not Applicable (1011-9000-000); ANAM01317, Not Applicable (1011-9000-000); ANAM01318, Not Applicable (1011-9000-000); ANAM01320, Not Applicable (1011-9000-000); ANAM01324, Not Applicable (1011-9000-000); ANAM01325, Not Applicable (1011-9000-000); ANAL01313, Not Applicable (1011-9000-000); ANAL01314, Not Applicable (1011-9000-000); ANAL01315, Not Applicable (1011-9000-000); ANAL01316, Not Applicable (1011-9000-000); ANAL01317, Not Applicable (1011-9000-000); ANAL01318, Not Applicable (1011-9000-000); ANAL01319, Not Applicable (1011-9000-000); ANAL01320, Not Applicable (1011-9000-000); ANAM01302, Not Applicable (1011-9000-000); ANAM01304, Not Applicable (1011-9000-000); ANAN00487, Not Applicable (1011-9000-000); ANAN00488, Not Applicable (1011-9000-000); ANAN00489, Not Applicable (1011-9000-000); ANAN00490, Not Applicable (1011-9000-000); ANAN00491, Not Applicable (1011-9000-000); ANAN00492, Not Applicable (1011-9000-000); ANAR05143, Not Applicable (1011-9000-000); ANAR05144, Not Applicable (1011-9000-000); 5450447-2, Not Applicable (2097674-NL); 5450447-4, Not Applicable (2097674-NL); 5454351-1, Not Applicable (2097674-NL); 5454351-2, Not Applicable (2097674-NL); ANAR00198, Not Applicable (1011-9000-000); ANAR00199, Not Applicable (1011-9000-000); ANAR00200, Not Applicable (1011-9000-000); ANAR00279, Not Applicable (1011-9000-000); ANAM01311, Not Applicable (1011-9000-000); ANAM01314, Not Applicable (1011-9000-000); ANAM01316, Not Applicable (1011-9000-000); ANAM01319, Not Applicable (1011-9000-000); ANAM01321, Not Applicable (1011-9000-000); ANAM01322, Not Applicable (1011-9000-000); ANAM01323, Not Applicable (1011-9000-000); 5456012-1, Not Applicable (2097674-001); 5456012-2, Not Applicable (2097674-001); 5456012-3, Not Applicable (2097674-001); 5456719-1, Not Applicable (2097674-001); ANAN01065, Not Applicable (1011-9000-000); ANAN01066, Not Applicable (1011-9000-000); 5476468-1, Not Applicable (2097674-001); 5476468-10, Not Applicable (2097674-001); 5476468-11, Not Applicable (2097674-001); 5476468-12, Not Applicable (2097674-001); 5476468-13, Not Applicable (2097674-001); 5476468-14, Not Applicable (2097674-001); 5476468-15, Not Applicable (2097674-001); 5476468-16, Not Applicable (2097674-001); 5476468-17, Not Applicable (2097674-001); 5476468-2, Not Applicable (2097674-001); 5476468-3, Not Applicable (2097674-001); 5476468-4, Not Applicable (2097674-001); 5476468-5, Not Applicable (2097674-001); 5476468-6, Not Applicable (2097674-001); 5476468-7, Not Applicable (2097674-001); 5476468-8, Not Applicable (2097674-001); 5476468-9, Not Applicable (2097674-001); Additional Serial Numbers - Model Number, UDI Number, (Serial Number): 2097674-001-US, Not Applicable, (APWV01271); 2097674-001-US, Not Applicable, (APWU01812); 2097674-001-US, Not Applicable, (ANAR00714); 2097674-001-US, Not Applicable, (ANAR00741); 2097674-001-US, Not Applicable, (ANAS00330); 2097674-001-US, Not Applicable, (ANAS01319); 2097674-001-US, Not Applicable, (ANAS01320); 2097674-001-US, Not Applicable, (APWU00486); 2097674-001-US, Not Applicable, (APWU00487); 2097674-001-US, Not Applicable, (APWU00575); 2097674-001-US, Not Applicable, (APWU01267); 2097674-001-US, Not Applicable, (APWX00154); 2097674-001-US, Not Applicable, (APWX00155); 2097674-001-US, Not Applicable, (APWX00156); 2097674-001-US, Not Applicable, (APWX00157); 1011-9000-000, Not Applicable, (ANAS00456); 2097674-001-US, Not Applicable, (ANAM00764); 2097674-001-US, Not Applicable, (ANAM00765); 2097674-001-US, Not Applicable, (ANAM00766); 2097674-001-US, Not Applicable, (ANAM00767); 2097674-001-US, Not Applicable, (ANAM00768); 2097674-001-US, Not Applicable, (ANAM00769); 2097674-001-US, Not Applicable, (ANAM00770); 2097674-001-US, Not Applicable, (ANAM00771); 2097674-001-US, Not Applicable, (ANAM00772); 2097674-001-US, Not Applicable, (ANAM00773); 2097674-001-US, Not Applicable, (ANAM00774); 2097674-001-US, Not Applicable, (ANAM00775); 2097674-001-US, Not Applicable, (APWV00946); 2097674-001, Not Applicable, (ANAL00264); 2097674-001, Not Applicable, (ANAL00265); 2097674-001, Not Applicable, (ANAL00266); 2097674-001, Not Applicable, (ANAK00415); 2097674-001, Not Applicable, (ANAK00703); 2097674-001, Not Applicable, (ANAK00705); 2097674-001, Not Applicable, (ANAK00707); 2097674-001, Not Applicable, (ANAK00709); 2097674-001, Not Applicable, (ANAK00410); 2097674-001, Not Applicable, (ANAK00411); 2097674-001, Not Applicable, (ANAK00413); 2097674-001, Not Applicable, (ANAK00414); 2097674-001, Not Applicable, (ANAK00416); 2097674-001, Not Applicable, (ANAK00417); 2097674-001, Not Applicable, (ANAK00421); 2097674-001, Not Applicable, (ANAL00893); 2097674-001, Not Applicable, (APWU02246); 2097674-001, Not Applicable, (APWV00404); 2097674-001, Not Applicable, (ANAK00412); 2097674-001, Not Applicable, (ANAK00418); 2097674-001, Not Applicable, (ANAK00419); 2097674-001, Not Applicable, (ANAK00420); 2097674-001, Not Applicable, (ANAK00704); 2097674-001, Not Applicable, (ANAK00706); 2097674-001, Not Applicable, (ANAK00708); 2097674-001, Not Applicable, (APWW00334); 1011-9000-000, Not Applicable, (ANAR05371); 2097674-DE, Not Applicable, (ANAS00870); 1011-9000-000, Not Applicable, (ANAR00333); 1011-9000-000, Not Applicable, (ANAJ00122); 1011-9000-000, Not Applicable, (ANAQ01270); 1011-9000-000, Not Applicable, (ANAQ01271); 1011-9000-000, Not Applicable, (ANAQ01272); 1011-9000-000, Not Applicable, (ANAQ01273); 1011-9000-000, Not Applicable, (ANAQ01274); 1011-9000-000, Not Applicable, (ANAQ01275); 1011-9000-000, Not Applicable, (ANAQ01276); 1011-9000-000, Not Applicable, (ANAQ01277); 1011-9000-000, Not Applicable, (ANAR00187); 1011-9000-000, Not Applicable, (ANAR00188); 1011-9000-000, Not Applicable, (ANAR00189); 1011-9000-000, Not Applicable, (ANAR00190); 1011-9000-000, Not Applicable, (ANAR00191); 1011-9000-000, Not Applicable, (ANAR00192); 1011-9000-000, Not Applicable, (ANAR00334); 1011-9000-000, Not Applicable, (ANAR00701); 1011-9000-000, Not Applicable, (APWU02039); 1011-9000-000, Not Applicable, (APWW01068); 2097674-001, Not Applicable, (ANAQ00825); 1011-9000-000, Not Applicable, (ANAR05370); 2097674-FR, Not Applicable, (ANAN01100); 1011-9000-000, Not Applicable, (ANAT00157); 1011-9000-000, Not Applicable, (ANAT00158); 1011-9000-000, Not Applicable, (ANAT00156); 1011-9000-000, Not Applicable, (ANAR05372);

Distribution

Worldwide distribution - US nationwide in the states of CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, ,MA, MD, MI, MN, MO, MT, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Countries of Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea (Republic of), Kuwait, Macedonia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

Quantity

4,207 units total