FDA-Device2023-11-15Class II
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Maquet Medical Systems USA
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.
Sold states
US Nationwide.
Affected count
1022 units
Manufactured in
45 Barbour Pond Dr, Wayne, NJ, United States
Products
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0290-2024Don't want to check this manually?
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