Recall Z-0589-2024— Maquet Cardiovascular, LLC
Class II · Ongoing
Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2023-10-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Acrobat-i Vacuum Positioner System, Model Number XP-5000Z. Reason: The Positioner Arm may not tighten or lock during normal use..
- Recalling firm
- Maquet Cardiovascular, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-31
- Firm location
- Wayne, NJ, United States
Product description
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Reason for recall
The Positioner Arm may not tighten or lock during normal use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.