Reported Aug 21, 2013 · Terminated
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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.
- Lot codes and dates
- 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 #1
1,129 of 1,129 codes
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
097 of 97 codes
00000227408MRI00000264599MR200000269459MR400000227571MR700000280698MR200000267974MR400000257743MR500000277607MR800000283437MR200000281681MR700000278622MR600000272529MR900000260098MR900000280620MR600000239523MR400000270627MR300000274711MR100000267040MR400000281022MR400000273621MR300000267211MR100000257744MR300000264408MR600000265610MR600000274713MR700000281314MR500000281273MR300000270550MR700000269342MR200000261477MR400000273341MR800000269382MR800000272105MR800000273368MR100000280274MR200000266156MR900000272962MR200000265616MR300000261736MR300000270321MR300000278768MR700000278076MR500000276486MR800000250454MR600000266822MR600000263503MR500000279798MR300000283665MR800000278875MR000000279755MR300000266011MR600000269460MR200000276152MR600000276414MR000000273230MR300000272406MR000000262800MR600000269574MR000000269457MR800000283365MR5
1498 of 498 codes
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
1183 of 183 codes
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
119 of 119 codes
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
- 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 #
- Amount recalled
- 7016 (2919 US; 4097 OUS)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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