Maquet Medical Systems USA recalls Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Sl…

Recall date

October 12, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0290-2024

FDA classification

Class II

Brand / firm

Maquet Medical Systems USA

Sold / distributed

US Nationwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)