CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Reported: May 22, 2024 Initiated: April 15, 2024 #Z-1831-2024
Product Description
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Reason for Recall
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
Details
- Recalling Firm
- Maquet Medical Systems USA
- Units Affected
- 148 units (US: 5; OUS: 143)
- Distribution
- US Nationwide distribution in the states of NJ & TX.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.. Recalled by Maquet Medical Systems USA. Units affected: 148 units (US: 5; OUS: 143).
Why was this product recalled? ▼
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2024. Severity: Moderate. Recall number: Z-1831-2024.
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