FDA Device recall Z-2266-2013
GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4…
- FDA Device
- Class II
- terminated
- Published 2013-10-02
On 2013-10-02 the FDA classified a Class II recall of GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4… by Ge Healthcare, citing GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and Scr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2266-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-09 |
| Published | 2013-10-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T. The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. IT is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used
Reason
GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and Screen Save from GVTK (Gems Visualization ToolKit) Viewer, the MR Product can generate image headers with non-unique series identifiers, which when exported to some PACS systems, results in the series being associated wit
Identifiers
| code_info | REF 60850 Mfg Lot or Serial # 00000204882MR5 00000233303MR7 00000241103MR1 00000245171MR4 00000247204MR1 0000017…REF 60850 Mfg Lot or Serial # 00000204882MR5 00000233303MR7 00000241103MR1 00000245171MR4 00000247204MR1 00000173038MR1 00000136104MR7 00000264553MR9 00000265096MR8 00000005532YR7 00000007097YR9 00000007556YR4 00000281841MR7 00000289583MR7 0000SGH919066P 00000013883YR4 0000SGH231PPQK 00002UA2050JKX 00002UA2400LWP 00002UA24315PT 00002UA24315PY 00002UA24315P5 00002UA24907W7 00000266797MRO 00000267189MR0 00000270550MR7 00000283466MR1 00000305180MR2 00000306054MR8 0000267533MR8A Not Available 00000237000MR5 00000226580MR9 00000230105MR9 00000285956MR9 00000305386MR5 00000012562YR5 Not Available 000002UA4907WH 00002UA2400LWZ 00000177845MR5 00000165805MR3 00000836BD4DE2 00000012383YR6 00000269416MR4 Not Available 00002UA2400LWN 00000284254MR0 00000287469MR1 00000304797MR4 00002UA24907WK 00000005220YR9 00002UA2420VVZ 00002UA24907YC 00002UA24907YD 00002UA2510YTL 00000287996MR3 00000934BD5E4F 00000005966YR7 00000919BD5B8F 00000285151 |
|---|
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-2266-2013%22
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