Leica ARveo and M530 OH6 microscope systems.
Enforcement
- Recall Number
- Z-2399-2020
- Event ID
- 85722
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Leica Microsystems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 24, 2020
- Initiation Date
- May 20, 2020
- Classification Date
- June 17, 2020
- Termination Date
- May 13, 2021
- Address
- 1700 Leider Ln, Buffalo Grove, IL, 60089-6622, United States
Description
Leica ARveo and M530 OH6 microscope systems.
Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
M530 OH6 Serial Numbers for Model # 10448680 OH6-016215, OH6-042317, OH6-032016, OH6-009815,OH6-044518 and OH6-030016. Arveo Serial Numbers for Model # 10448999 OHA-006318, OHA-010719, OHA-011919, OHA-000818, OHA-009119, OHA-000718, OHA-014919, OHA-016619, OHA-015919, OHA-007818, OHA-013519, OHA-001218, OHA-012219, OHA-017319, OHA-000418, OHA-017119, OHA-013719, OHA-009919, OHA-017219, OHA-017419, OHA-002218, OHA-000318, OHA-014819, OHA-015219, OHA-003718, OHA-001018, OHA-016019, OHA-012919, OHA-012619, OHA-011719, OHA-012119, OHA-010819, OHA-016119, OHA-009219, OHA-002618, OHA-015719, OHA-012019, OHA-009519, OHA-000618, OHA-008518, OHA-004818, OHA-012719, OHA-010619, OHA-001118, OHA-010419, OHA-016319, OHA-016519, OHA-010219, OHA-012519, OHA-015419, OHA-009018, OHA-016419, OHA-016719, OHA-008918, OHA-007618, OHA-009619, OHA-012319, OHA-010519, OHA-005418.
Domestic distribution: AL,AR,AZ, CA, CT, DC, DE, FL, IL, KY, LA, MI, MN, MO, NC, NY, OH. OR. TN, TX, UT, VA, WA, WI ,WV. International distribution: Japan
Domestic distribution 65 devices. International distribution 12 devices. Total of devices distributed 77.