Recall Z-0082-2014 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Maquet Medical Systems USA
MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.
| Date | Oct 25, 2013 (initiated Sep 12, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | MAQUET issued their customers "Urgent-Medical Device Field Correction" notices/Customer Fax Response forms dated September 16, 2013 via FedEx on September 16, 2013. The notification informs the customer of the issue with the product; how to identified affected product; and the action needed to be taken by the customer. The field correction includes service on the affected product. Authorized MAQUET Service Technicians will service the affected product to correct the issue. Customers were requested to complete and fax back (or email a scanned copy) of the enclosed response form. Customers |
| Quantity | 63 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102726 | CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG, Apr 4, 2011 |