Z-0290-2024 Class II Ongoing
FDA device recall Z-0290-2024 was initiated by Maquet Medical Systems USA on October 12, 2023 and is designated Class II. Reason for recall: 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 w… The recall status is ongoing. Affected quantity: 1022 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2023
- Initiation Date
- October 12, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1022 units
Product Description
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Reason for Recall
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.
Distribution Pattern
US Nationwide.
Code Information
UDI-DI: 04058863074863; Serial Numbers: 90414355 through 90414868