Maquet Medical Systems USA 2024-05-22 Health serious FDA
Health · FDA · Recall #FDA-Z-1831-2024
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. Recall
Issued May 22, 2024 · Maquet Medical Systems USA
In May 2024, Maquet Medical Systems USA recalled the CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system., a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
What you should do
- 1 Stop using CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Maquet Medical Systems USA to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Maquet Medical Systems USA
- Category
- Health
- Recall date
- May 22, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of NJ & TX.
- Recall number
- FDA-Z-1831-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Maquet Medical Systems USA has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.