Moderate FDA (Devices)·Z-0082-2014·Announced 2013-11-06

Maquet CARDIOHELP Base Unit Recalled for Display and Alarm Defects

Maquet Medical Systems USA is recalling 63 CARDIOHELP Base Units because they may display error messages and have touch screens that turn black.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The source describes functional defects (display and alarm issues) without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate risk of harm.

Plain-English summary

Maquet Medical Systems USA is recalling 63 units of the MAQUET Getinge Group CARDIOHELP Base Unit (Part No. 70104.8012). The affected devices are cardiopulmonary support systems manufactured in Germany for MAQUET Cardiopulmonary AG. The recall covers units distributed nationwide, including in Arizona, Florida, Colorado, Texas, Ohio, Virginia, Minnesota, Wisconsin, South Carolina, Illinois, North Dakota, Utah, California, Oregon, New York, Iowa, Connecticut, South Dakota, Michigan, Hawaii, Alabama, Maryland, Kansas, and Missouri.

The recall was initiated because, in certain rare instances, the CARDIOHELP-i device may display an error message with an audible alarm indicating "battery defective." This alarm may occur upon startup or when the main power supply is unplugged. Additionally, the human machine interface (HMI) touch screen may gradually become black due to the HMI back light shutting down.

The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these devices.

The recalled product

Product: MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.
Manufacturer: Maquet Medical Systems USA
Category: Medical Device — Cardiopulmonary Support
Hazard: display-failure
false-alarm
Affected units: 63

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Part No. 70104.8012 Serial Nos. 90410440
90410452
90410455
90410456
90410457
90410459
90410469
90410474
90410480
904104781
90410482
90410484
90410498
90410499
90410500
90410501
90410502
90410503
90410521
90410522

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Same manufacturer · Maquet Medical Systems USA

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