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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Event Detail

Event ID 66336
Product Type Devices
Status Ongoing
Recalling Firm Maquet Medical Systems USA
City Wayne
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-12
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system. 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; 90410524; 90410526; 90410527; 90410531; 90410533; 90410534; 90410535; 90410550; 90410551; 90410552; 90410568; 90410571; 90410572; 90410573; 90410575; 90410576; 90410577; 90410580; 90410581; 90410582; 90410584; 90410585; 90410592; 90410596; 90410599; 90410600; 90410605; 90410606; 90410607; 90410608; 90410609; 90410610; 90410611; 90410612; 90410626; 90410638; 90410640; 90410642; 90410644; 90410646; 90410647; 90410650; 90410651; 90410652; 90410653; 90410656; 90410659; 90410660; 90410661; 90410662; 90410663; 90410664; 90410665; 90410666; 90410667; 90410668; 90410670; 90410700; 90410708; 90410846; 90410750; 90410786 Class II 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. 63 Z-0082-2014
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