FDA recall Z-0589-2024
Maquet Cardiovascular, LLC · Class II · device
Product
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Reason for recall
The Positioner Arm may not tighten or lock during normal use.
Distribution
US Nationwide. Global Distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2023-10-31
- Report date
- 2023-12-27
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Wayne, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0589-2024