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Recall Observatory FDA recall evidence

Device product

Acrobat-i Vacuum Positioner System, Model Number XP-5000Z

Z-0589-2024

October 31, 2023

Class II

Product summary

Firm
Maquet Cardiovascular, LLC
Event
Event 93477
Status
Ongoing
Classification
Class II
Quantity
6472 units
Official record key
device-enforcement:Z-0589-2024

Official wording

Reason: The Positioner Arm may not tighten or lock during normal use.

Code information: 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 pattern: US Nationwide. Global Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Positioner Arm may not tighten or lock during normal use.