RecallRadar

FDA Device recall Z-0024-2014

GE PET Discovery 610, PET Discovery 710

On 2013-10-23 the FDA classified a Class II recall of GE PET Discovery 610, PET Discovery 710 by Ge Healthcare, citing GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0024-2014
ClassificationClass II
Statusterminated
Initiated2013-03-26
Published2013-10-23
Last updated2026-09-13 11:53 UTC
CompanyGe Healthcare
DistributionUS

Product

GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.

Reason

GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID

Identifiers

code_info
MfgLotorSerial# 00000428413CN9 00000429077CN1 00000429247CN0 00000430152CN9 00000430656CN9 00000430999CN3 000004…MfgLotorSerial# 00000428413CN9 00000429077CN1 00000429247CN0 00000430152CN9 00000430656CN9 00000430999CN3 00000431369CN8 00000429701CN6 00000430064CN6 00000431187CN4 00000429354CN4 00000431447CN2 00000293950HM2 00000429821CN2 00000429946CN7 00000430001CN8 00000293950HM2 00000430632CN0 Shipped Shipped Shipped 00000429572CN1 00000428755CN3 00000428755CN3 00000428868CN4 00000293949HM4 00000428536CN7 00000429820CN4

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0024-2014%22

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