MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made

FDA device recall Z-0082-2014 · posted 2013-10-25 · Terminated

Recall details

Recalling firm

Maquet Medical Systems USA

Reason for recall

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.

Action taken

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 could contact their local field representative or the MAQUET Customer Service line at 1.888.627.8383 (press option 2 followed by option 2) Monday through Friday, 8am to 6pm EST. For questions regarding this recall call 973-709-7000.

Root cause

Software Manufacturing/Software Deployment

Status

Terminated

Product code

DTQ

Quantity affected

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

Date initiated

2013-09-12

Date posted

2013-10-25

Date terminated

2017-06-07

Location

Wayne, NJ

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