FDA Device recall Z-1245-2014
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series o…
- FDA Device
- Class II
- terminated
- Published 2014-03-26
On 2014-03-26 the FDA classified a Class II recall of GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series o… by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1245-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-14 |
| Published | 2014-03-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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
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)
Identifiers
| code_info | Mfg Lot or Serial # PA2314840 PA2314841 PA2314842 PA2314843 PA2314844 PA2314845 A1RF3176G A1RF3638GR A2RF1052G…Mfg Lot or Serial # PA2314840 PA2314841 PA2314842 PA2314843 PA2314844 PA2314845 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 D2RF2820G D2RF2821G D2RF2822G D2RF2823G D2RF2824G D2RF2825G D2RF2826G D2RF2827G D2RF2828G D2RF2829G D2RF2830G D2RF2831G D2RF2832G D2RF2833G D2RF2834G D2RF2835G D2RF2836G D2RF2837G D2RF2838G D2RF2839G D2RF2840G D2RF2841G D2RF2842G D2RF2843G D2RF2844G D2RF2845G D2RF2846G D2RF2847G D2RF2848G D2RF2850G D2RF2851G D3G44977G D3G44983G D3G44984G D3G44985G D43T4071G D43T4072G D43T4073G D43T4074G D43T4075G D43T4076G D43T4077G E1RF5364G E1RF5479GR E1RF5480GR E1RF5599G E3RF5317G E3RF5318G F0RF0134G F0RF0135G F0RF0136G F0RF0140G F0RF0141G F1RF4827GR F1RF5952G F1RF6042GR F1RF6075GR F1 |
|---|
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-1245-2014%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.