FDA Device recall Z-1943-2013
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…
- FDA Device
- Class II
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class II recall of 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… by Ge Healthcare, citing 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 o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1943-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-11-21 |
| Published | 2013-08-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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
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.
Identifiers
| code_info | Ref. # 60808 "Products: Signa Infinity MR System with EXCITE Technology, Signa EXCITE 1.5T and Signa EXCITE 3.0T, Si…Ref. # 60808 "Products: Signa Infinity MR System with EXCITE Technology, Signa EXCITE 1.5T and Signa EXCITE 3.0T, Signa 3T with EXCITE, Signa 3T Infinity with EXCITE, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM (Waukesha, WI) FMI 60808" Mfg Lot or Serial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|
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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-1943-2013%22
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