Reported Feb 5, 2020 · Terminated
SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner…
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 Pioneer Nuclear Magnetic Resonance
- Imaging System - 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 ID To be providedTo be provided 83199160995 To be provided M24313812 To be provided M2850013 To be provided TP0013MR01 To be provided PNUE04MR02 To be provided TP0008MR07 To be provided 083027823408018 To be provided 083027823888617 To be provided GON4826677 To be provided GON4762453 To be provided B5142305 To be provided ZC0002 To be provided ZC0034 To be provided ZC0001 To be provided ZC0306 To be provided GON4795546 To be provided 222768MR01 To be provided 34340MRS02 To be provided 10627MRS02
GON483310001264860536MR3TKZTBL1700064TJ860871MR3TKZTBL1800069TJRADNETMR1700KZTBL1800022TJ508872PMR01302RADNETMR1708KZTBL1900130TJ301698MR1KZTBL1900071TJ704333PIOKZTBL1900110TJ631751MRKZTBL1900107TJRADNETMR1707KZTBL1900121TJ803936LMCMR2033-4-1532281HMI750W
- Mfg. Lot or Serial # System ID To be provided
- 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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