GE Healthcare — Class II medical device recall Z-0981-2014
Terminated recall by GE Healthcare, LLC, reported 2014-02-26, distributed in AL, AR, AZ, CA, CO, FL, GA, IA…. GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated w
| Recall number | Z-0981-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-11-20 |
| Classified | 2014-02-14 |
| Reported by FDA | 2014-02-26 |
| Terminated | 2014-07-29 |
| Distributed | 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 |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, HK, HR, IL, IN, IR, IT, JO, JP, KR, KW, LB, MA, MX, MY, NO, NZ, PL, RO, RU, SA, SE, TH, TN, TR, TW |
| UPC / GTIN / UDI-DI | 83045029088212 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0981-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.