Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM 630

FDA device recall Z-1791-2013 · posted 2013-07-24 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re

Action taken

GE sent an Urgent Medical Device Correction letter dated June 17, 2013 to all affected customers. The letter identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures are executed according to labeling. Also the Safety Chapter Sections should be re-reviewed with personnel to ensure proper operation of the equipment. GE notified customers again on July 03, 2013, via Urgent Medical Device Recall letter (including confirmation of delivery for US customers) and follow-up telephone call. Customers were instructed to cease using the affected system until GE Healthcare Field Engineer can complete an inspection of the system and perform any necessary repairs at no cost. A GE Healthcare representative will contact the hospitals to arrange for the inspection.

Root cause

Device Design

Status

Terminated

Product code

KPS

Quantity affected

108

Distribution

Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Ri

Date initiated

2013-06-13

Date posted

2013-07-24

Date terminated

2014-06-19

Location

Waukesha, WI

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