Recall Z-1053-2024— Maquet Medical Systems USA

Name: FDA recall Z-1053-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-28

Class II · Ongoing

Class II FDA medical device recall by Maquet Medical Systems USA, initiated 2023-12-28. It names one FDA 510(k) clearance: K133598. Product: Bubble Sensor (REF: 70105.5720). Reason: The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device..

Recalling firm: Maquet Medical Systems USA
Classification: Class II
Status: Ongoing
Initiated: 2023-12-28
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

Bubble Sensor (REF: 70105.5720)

Reason for recall

The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.

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