Maquet Medical Systems USA recalls Bubble Sensor (REF: 70105.5720)

Recalled February 14, 2024 · FDA recall Z-1053-2024 · Maquet Medical Systems USA

Hazard

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. · FDA Class II

Units

274 units (70 US, 204 OUS)

Sold at

AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.

Description

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.

Product

Bubble Sensor (REF: 70105.5720)

Manufacturer(s)

Maquet Medical Systems USA

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →