Recall Z-0290-2024— Maquet Medical Systems USA

Name: FDA recall Z-0290-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-12

Class II · Ongoing

Class II FDA medical device recall by Maquet Medical Systems USA, initiated 2023-10-12. It names one FDA 510(k) clearance: K133598. Product: Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder). Reason: 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..

Recalling firm: Maquet Medical Systems USA
Classification: Class II
Status: Ongoing
Initiated: 2023-10-12
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K133598 — CARDIOHELP SYSTEMMaquet Cardiopulmonary, AG·cleared 2014-05-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.