GE 1 — Class II medical device recall Z-2266-2013
Terminated recall by GE Healthcare, LLC, reported 2013-10-02, distributed in AK, AZ, DC, RI, WY. GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embed
| Recall number | Z-2266-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-04-09 |
| Classified | 2013-09-23 |
| Reported by FDA | 2013-10-02 |
| Terminated | 2014-05-05 |
| Distributed | AK, AZ, DC, RI, WY |
| Countries outside the US | AE, AT, AU, BE, BH, BR, CA, CH, CL, CN, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HU, ID, IL, IN, IT, JP, KR, KW, LU, MX, NL, NO, NZ, PL, PT, QA, RO, RS, RU, SA, SE, SG, TR, TW, UY, VN, ZA |
| Serial numbers | 00000000UA0009, 00000000UA0010, 00000000UA0012, 00000000UA0015, 00000000UA0016, 00000000UA0018, 00000000UA0019, 00000000UA0020, 00000000UA0021, 00000000UA0022, 00000000UA0023, 00000000UA0024, 00000000UA0025, 00000000UA0026, 00000000UA0027, 00000000UA0028, 00000000UA0029, 00000000UA0030, 00000000UA0031, 00000000UA0034, 00000000UA0035, 00000000UA0036, 00000000UA0037, 00000000UA0038, 00000000UA0039 and 475 more |
| Model numbers | 2377062-61, 2395001, 2395001-2, 2395001-3, 2395001-4, 5127452, 5127452-3, 5269997-2, 5269997-4, 53085735308573-2, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 60850 |
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 for recall
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
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-2266-2013. 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.