FDA Enforcement
Class II
Ongoing
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Recall: Z-0589-2024
·
Reported December 27, 2023
Enforcement
- Recall Number
- Z-0589-2024
- Event ID
- 93477
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Maquet Cardiovascular, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 27, 2023
- Initiation Date
- October 31, 2023
- Classification Date
- December 19, 2023
- Address
- 45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States
Description
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Reason
The Positioner Arm may not tighten or lock during normal use.
Code Info
UDI-DI: 00607567500006; Lot Numbers: 3000195267, 3000195268, 3000195273, 3000195663, 3000199248, 3000199725, 3000204637, 3000207240, 3000211594, 3000212053, 3000213219, 3000214053, 3000214054, 3000214255, 3000221064, 3000214052, 3000225770, 3000226531, 3000225866, 3000225769, 3000231209, 3000231210
Distribution
US Nationwide. Global Distribution.
Quantity
6472 units