FDAFDA · Food and drugs·Recall number Z-0290-2024
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Published November 15, 2023 · Recall initiated: October 12, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Medical Systems USA
- Distributor
- US Nationwide.
- Lot
- UDI-DI: 04058863074863; Serial Numbers: 90414355 through 90414868
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.