FDA Enforcement Class II Ongoing

Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.

Recall: Z-2420-2025 · Reported September 3, 2025

Enforcement

Recall Number
Z-2420-2025
Event ID
97313
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
MAQUET GMBH
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
September 3, 2025
Initiation Date
July 14, 2025
Classification Date
August 22, 2025
Address
Kehler Str. 31, Rastatt, N/A, Germany

Description

Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.

Reason

Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override panel.

Code Info

Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; UDI-DI: (1) 04046768145177, (2) 04046768145184, (3) 04046768145191, (4) 04046768145207, (5) 04046768145214, (6) 04046768145221; Lot/Serial Numbers: (1) 1, 2, 3, 10, 25, 26, 27, 28, 22, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 24, (2) 9, 51, 53, 14, 15, 16, 17, 34, 35, 36, 37, 39, 40, 42, 43, 54, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 38, 44, 45, 46, 5, 13, 57, 58, 59, 18, 49, 47, 48, 7, 52, (3) 41, 5, 6, 45, 48, 49, 50, 23, 38, 10, 12, 13, 14, 84, 87, 88, 89, 7, 63, 80, 82, 83, 86, 54, 93, 94, 11, 15, 18, 20, 21, 22, 27, 28, 32, 40, 9, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 85, 55, 56, 57, 58, 59, 42, 97, 92, 17, 26, 16, 24, 25, 30, 33, 35, 36, 37, 39, 44, 53, 91, 8, 19, 90, 46, 47, 51, 52, 34, 43, 60, 62, 64, 65, 66, 67, 68, (4) 44, 70, 71, 42, 56, 65, 115, 185, 52, 105, 106, 107, 109, 145, 146, 147, 148, 11, 26, 19, 32, 33, 35, 36, 39, 53, 61, 63, 69, 14, 20, 68, 13, 18, 16, 101, 167, 170, 83, 3, 4, 23, 28, 37, 38, 40, 41, 43, 45, 47, 48, 50, 55, 58, 60, 62, 78, 81, 82, 92, 94, 96, 97, 98, 99, 100, 102, 116, 138, 139, 144, 150, 152, 153, 154, 155, 156, 165, 169, 171, 21, 22, 24, 25, 6, 17, 27, 29, 30, 34, 49, 51, 57, 64, 74, 75, 76, 77, 79, 80, 84, 85, 86, 87, 88, 89, 90, 91, 93, 95, 103, 104, 108, 110, 111, 112, 113, 114, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 140, 141, 142, 143, 172, 173, 174, 194, (5) 1, 2, 3, 4, 5, 6, 7, (6) 12, 15;

Distribution

Worldwide - US Nationwide distribution in the states of KY, NY, TX and the countries of Algeria, Australia, Austria, Bulgaria, Canada, China, Colombia, Denmark, Egypt, Estonia, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Lebanon, Morocco, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom.

Quantity

315 units (8 US, 307 OUS)