Reported Aug 14, 2024 · Ongoing
Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0,…
GE Medical Systems, 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 Medical Systems, LLC · 3200 N Grandview Blvd · Waukesha, WI · 53188-1693
Is this the product you have?
- Discovery MR750w 3.0T
- with affected software versions
DV24.0DV25.0DV25.1DV26.0 to DV26.5DV29.1MR30.0MR30.1Nuclear Magnetic Resonance Imaging System
- Lot codes and dates
- System ID
724 of 724 codes
9075653T2059953T2567373T251639MR3T334273CIC750W479571MANASMIDOB750W602863MR480265MR1480342MR3SMIMCK750WRADNETMR597530CHI750W840200DVMR1562869DVMR916V53TMR657293MR1949777MR1858824MR1858622HDMR1562826MR2213223DVMR408356MR1310554DVMRRADNETMR599949760MR3510449MR750W805779MR3619543HDMR4CALPAC750415SLMR750415UCBHMR3RADNETMR613415CB3TW310264MR2415723SHMR20415723SHMR12805434MR3310802DVMRRADNETMR621559734VIMR1RADNETMR598720848MR4303492MR720854MR719255MR719365MR303837MR2970764MR303788MR63034682202MR303604MR2970624MR1MDF020-1-2665NP18303577DVMR2856247MR3860446MR750W202966MR3TW302430MR750W2302430MR750W
- System ID
- Amount recalled
- 724 units
This recall covers 26 products
The agency filed one notice per product. You are reading one of them; the other 25 are below.
13 more are in the archive.
Why it was recalled
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
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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