Reported Nov 18, 2015 · Terminated
GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for…
GE Healthcare
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 · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare, SIGNA 3.0T
- Product UsageMagnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomen/Thorax and the extremities
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 00000GE0206027082427040020— 00000243366MR208242704004000000256194MR2 409740MR01 00000261205MR9 083027828659711 00000280097MR7 IE1111MR01 00000189273MR6 A5155133 00000272076MR1 YM0222 00000267372MR1 YM033300000000004230YM0451 00000271322MR0 0850270094 00000227450MR7 333MR3TXXX 00000271777MR5 5606MRS3T 00000273539MR7 570844HCM3T 00000227450MR7 333MR3T 000000HDMR5684 CEN03406 00000GE0209032 0853270052IB1 00000260651MR5 10491MRS01 - Amount recalled
- 19
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
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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