SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3 — Class II medical device recall Z-1943-2013
Terminated recall by GE Healthcare, LLC, reported 2013-08-21, distributed nationwide. Screen save images are included in wrong exam due to duplicate UID creation. This may cause a safety issue due
| Recall number | Z-1943-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2011-11-21 |
| Classified | 2013-08-09 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2014-10-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KR, KW, LB, LU, LV, MA, MT, MX, MY, NG, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, TH, TN, TW, UA, UY, VE, VN, ZA |
| Serial numbers | 0.35T, 0.7T, 0000000000XXXX, 00000000100YR8, 00000000102YR4, 00000000109YR9, 00000000113YR1, 00000000116YR4, 00000000117YR2, 00000000118YR0, 00000000119YR8, 00000000120YR6, 00000000122YR2, 00000000123YR0, 00000000124YR8, 00000000125YR5, 00000000127YR1, 00000000128YR9, 00000000129YR7, 00000000130YR5, 00000000132YR1, 00000000133YR9, 00000000134YR7, 00000000136YR2, 00000000137YR0 and 475 more |
| Model numbers | 0.35T, 0.7T, 60808, 67626, 67815 |
Product
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (i.e. Signa Ovation 5 and Ovation HD) GE 1.5T SIGNA HDe MR SYSTEM GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (4) WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (5) WITH EXCITE MR SYSTEM The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs 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. The images produced by the Signa Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Reason for recall
Screen save images are included in wrong exam due to duplicate UID creation. This may cause a safety issue due to a potential patient data mismatch.While the issue has only been observed at one customer site on the Signa HDxT 1.5T system, internal investigation revealed that the issue also impacts multiple GE healthcare MR Systems.
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-1943-2013. 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.