FDA Device recall Z-0981-2014
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690 by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0981-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-20 |
| Published | 2014-02-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KY, LA, MN, MO, NC, NE, NJ, NM, NY, OH, OK, PA, SD, TN, TX, UT, VA, WA, WI, WV |
Product
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems.
Reason
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.
Identifiers
| code_info | FMI 13715 Serial # System ID 00000012391PT9 530UCVETPET 00000012525PT2 RHCDISC710 00…FMI 13715 Serial # System ID 00000012391PT9 530UCVETPET 00000012525PT2 RHCDISC710 00000012544PT3 856247PETUPS 00000012561PT7 505216D710 00000012574PT0 858805PCT 00000012615PT1 630432D710 00000012674PT8 801581D710 00000012723PT3 602839D710 00000012732PT4 402327D610 00000012752PT2 719365PETCT 00000012771PT2 414805D710 00000012834PT8 904710PET 00000012843PT9 918505PETCT1 00000012849PT6 205975PET1 00000012865PT2 205975PET2 00000012896PT7 985542D610 00000012915PT5 256386HKPETCT 00000012924PT7 318675D710 00000012937PT9 504842D600 00000012961PT9 303673PETCT 00000012975PT9 605328D710 00000013017PT9 608WIMRD710 00000013057PT5 847872D610 00000013066PT6 4056793 00000013067PT4 212288DST710 00000013072PT4 002902086 00000013081PT5 253968D710 00000013101PT1 270688PETCT 00000012473PT5 910452029 00000012749PT8 910456003 00000012837PT |
|---|
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-0981-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.