Reported Aug 23, 2017 · Terminated
Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices…
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?
- Signa PET/MR (K163619
- K142098) Product UsageThe SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiationfree attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems
- Lot codes and dates
Medical Device Listing No. D117354D295466D182389D102432D206140D230310D269569D102430D140572D188736D102434D234841D196247D134019D236543D006275D159181D288890D229859Model No. Eaton 913053232865396502-55499460-35499460-65499460-95741000-3008406821159715396502-25499460-25741000-2008406821158725373011-35396469-35481490-25481500-75499460-75499460-105741000008406821038175323286-1012377062-6123950012395001-22395001-32395001-400840682105699840682105378
- Amount recalled
- 68 units in total
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
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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