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Maquet Medical Systems USA recalls MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Mad
Recalled November 6, 2013 · FDA recall Z-0082-2014 · Maquet Medical Systems USA
Hazard
It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating "battery defective." The alarm will occur-upon start up or when the main power supply is unplugged from the main power source. The human machine interface touch screen of the CARDIOHELP-i device may gradually become black due to the human machine interface (HMI) back light shutting down. · FDA Class II
Units
63
Sold at
Nationwide Distribution including AZ, FL, CO, TX, OH, VA, MN, WI, SC, IL, ND, UT, CA, OR, NY, IA, CT, SD, MI, HI, AL, MD, KS, MO
Description
It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating "battery defective." The alarm will occur-upon start up or when the main power supply is unplugged from the main power source. The human machine interface touch screen of the CARDIOHELP-i device may gradually become black due to the human machine interface (HMI) back light shutting down.
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(s)
Maquet Medical Systems USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →