CLASS II Device recall · Reported 23 Aug 2017 · FDA Enforcement Report

Signa PET/MR (K163619, K142098) recalled by GE Medical Systems

GE Medical Systems is recalling Signa PET/MR (K163619, K142098), distributed nationwide in the US. The recall was initiated on 11 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMedical Device Listing No. D117354, D295466, D182389, D102432, D206140, D230310, D269569, D102430, D140572, D188736, D102434, D234841, D196247, D134019, D236543, D006275, D159181, D288890, D229859; Model No. Eaton 9130, 5323286, 5396502-5, 5499460-3, 5499460-6, 5499460-9, 5741000-3, 00840682115971, 5396502-2, 5499460-2, 5741000-2, 00840682115872, 5373011-3, 5396469-3, 5481490-2, 5481500-7, 5499460-7, 5499460-10, 5741000, 00840682103817, 5323286-101, 2377062-61, 2395001, 2395001-2, 2395001-3, 2395001-4, 00840682105699, 840682105378

Quantity recalled68 units in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3029-2017
FDA event ID: 77488
Recalling firm: GE Medical Systems, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 11 May 2017
FDA classified: 11 Aug 2017
Reported: 23 Aug 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

11 May 2017	Recall initiated by company
11 Aug 2017	Classified by FDA	+92 days
23 Aug 2017	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

Product as listed by the FDA

Signa PET/MR (K163619, K142098) Product Usage: The 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.

Where it was distributed

US Nationwide in the states of : AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI

Nationwide Alaska California Colorado Connecticut Delaware Florida Iowa Illinois Indiana Kansas Kentucky Louisiana Maryland Missouri North Dakota Nebraska New Jersey New York Ohio Pennsylvania

Questions about this recall

Why was it recalled?

Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

Which lots are affected?

Medical Device Listing No. D117354, D295466, D182389, D102432, D206140, D230310, D269569, D102430, D140572, D188736, D102434, D234841, D196247, D134019, D236543, D006275, D159181, D288890, D229859; Model No. Eaton 9130, 5323286, 5396502-5, 5499460-3, 5499460-6, 5499460-9, 5741000-3, 00840682115971, 5396502-2, 5499460-2, 5741000-2, 00840682115872, 5373011-3, 5396469-3, 5481490-2, 5481500-7, 5499460-7, 5499460-10, 5741000, 00840682103817, 5323286-101, 2377062-61, 2395001, 2395001-2, 2395001-3, 2395001-4, 00840682105699, 840682105378

Where was it sold?

US Nationwide in the states of : AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 77488

This product is part of a recall event; the main page for the event is Optima MR450 1.5T recalled by GE Medical Systems.

Reported	Class	Recall	Company	Reason	Where
23 Aug 2017	CLASS II	Optima MR450 1.5T recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
23 Aug 2017	CLASS II	Optima MR750 3.0T recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
23 Aug 2017	CLASS II	Optima MR450w 1.5T recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
23 Aug 2017	CLASS II	1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant recalled	GE Medical Systems	Other	Nationwide
23 Aug 2017	CLASS II	1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt recalled	GE Medical Systems	Other	Nationwide
23 Aug 2017	CLASS II	Signa Creator, Signa ExplorerProduct Usage recalled	GE Medical Systems	Other	Nationwide
23 Aug 2017	CLASS II	Discovery MR750 3.0T recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
23 Aug 2017	CLASS II	Brivo MR355, Optima MR360 recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide

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