Maquet Medical Systems USA: Device Recall
Recall #Z-1831-2024 · 04/15/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1831-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Maquet Medical Systems USA
- Status
- Ongoing
- Date Initiated
- 04/15/2024
- Location
- Wayne, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 148 units (US: 5; OUS: 143)
Reason for Recall
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
Product Description
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Distribution Pattern
US Nationwide distribution in the states of NJ & TX.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.