Reported Nov 6, 2013 · Terminated
MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG…
Maquet Medical Systems USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Medical Systems USA · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012
- Manufactured forMAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system
- Lot codes and dates
82 of 82 codes
Part No. 70104.8012 Serial Nos. 9041044090410452904104559041045690410457904104599041046990410474904104809041047819041048290410484904104989041049990410500904105019041050290410503904105219041052290410524904105269041052790410531904105339041053490410535904105509041055190410552904105689041057190410572904105739041057590410576904105779041058090410581904105829041058490410585904105929041059690410599904106009041060590410606904106079041060890410609904106109041061190410612904106269041063890410640904106429041064490410646
- Amount recalled
- 63
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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