GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are

FDA device recall Z-0981-2014 · posted 2014-02-14 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of your Discovery 600, 610, 710 and Discovery 690.

Action taken

GE Healthcare sent an Urgent Medical Device Correction letter dated November 20, 2013, and December 4, 2013, to all affected consignees. The letters described the Safety Issue, Safety Instructions, Affected Products Details, Product Correction and Contact Information ( In the US Call 1-800-437-1171. For other countries contact your local GE Healthcare Service Representative). Customers were given the following instructions: To avoid potential issues, replay the list mode data prior to another acquisition. In the event another acquisition is made before replaying the list data, or following reboot, do the following steps: Perform a PET only acquisition using the same tracer that is intended for the List Mode Replay. Then, proceed to perform the List Mode Replay and subsequent reconstructions. Make sure to perform a quality check on any images created after any replay of data. Affected Product Details PET Discovery 610 and PET Discovery 710, with software versions pet_coreload.44 and pet_mfk.44. The software version is visible on the homepage of the service desktop. To determine the software version currently on your system, do the following: 1. On the right monitor upper left corner select the Service Icon. 2. Verify that the Service window is under Home. 3. Locate the SW Build Version listed in the center of the page. For questions regarding this recall call 800-437-1171.

Root cause

Software Manufacturing/Software Deployment

Status

Terminated

Product code

KPS

Quantity affected

376 (101 US, 275 OUS)

Distribution

Worldwide Distribution - USA including AL, AZ, AR, CA, CO, FL, GA, IL, IN, IA, KY, LA, MN, MO, NE, NJ, NM, NY, NC, OH, OK, PA, SD, TN, TX, UT, VA, WA, WV, WI and Internationally to: AUSTRALIA, AUSTRIA

Date initiated

2013-11-20

Date posted

2014-02-14

Date terminated

2014-07-29

Location

Waukesha, WI

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