Maquet Medical Systems USA 2023-11-15 Health serious FDA
Health · FDA · Recall #FDA-Z-0290-2024
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780… Recall
Issued November 15, 2023 · Maquet Medical Systems USA
In November 2023, Maquet Medical Systems USA recalled the Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.
What you should do
- 1 Stop using Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780… 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
- November 15, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide.
- Recall number
- FDA-Z-0290-2024
- 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 903rd Health recall we've logged in 2023.