GE Healthcare Optima CT580/Discovery CT590RT scanners running… — Class II medical device recall Z-1245-2014
Terminated recall by GE Healthcare, LLC, reported 2014-03-26, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with th
| Recall number | Z-1245-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-02-14 |
| Classified | 2014-03-20 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2015-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, DZ, FR, PL, RU, TW |
| Reason classes | software |
| Serial numbers | A1RF3176G, A1RF3638GR, A2RF1052G, B1RF4038GR, B3G44377G, B3G44511G, B3G44515G, B3RF4960G, C1RF4686G, C1RF4793G, C1RF4802G, C1RF4827GR, D2RF2744G, D2RF2778GR, D2RF2795G, D2RF2796G, D2RF2797G, D2RF2798G, D2RF2799G, D2RF2814G, D2RF2815G, D2RF2816G, D2RF2817G, D2RF2818G, D2RF2819G and 475 more |
Product
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated (Respiratory and Cardiac) acquisitions in patients of all ages.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your Optima CT580 or Discovery CT590RT scanner. A potential hazardous situation may occur during a CT head scan causing a novel and rare artifact that may hide pathology. When using the head and large head SFOV, which applies the Iterative Bone Option (IBO)
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-1245-2014. 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.