Reported Feb 5, 2020 · Terminated
SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is…
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 Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt
- Signa HDi - Product Usageis a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times
- Lot codes and dates
- Mfg. Lot or Serial # System IDTo be provided GON4796599 To be provided 424881MR01 To be provided 083027829345912 To be provided 083027862100408
22D-4-0868901BMHCRITMRHDGOC1900010SC209521SGMRHDGOC1900015SC4577711MR11002776WHF954916MR1022D-4-1175808243MR857LONGWOOD30MR200000290815MR0508580BMR3002801WHF734246MR002930WHF845279MR00000269040MR2412749MR1022D-4-1125801RIVMR2HDGOC1900003SC206386SMRH051144815915MR1100000277443MR8304526SMR1
- Mfg. Lot or Serial # System ID
- Amount recalled
- 62 (30 US, 32 OUS) total devices
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
- Nationwide
Why it was recalled
It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system s date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.
This product could cause temporary or reversible health problems — stop using it.
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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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