Agency classClass IIOur severity:Severe FDA (Devices)·Z-0131-2021·Announced 2020-10-28

GE Healthcare Recalls PET/MR Imagers Due to Electrical Arc Flash Risk

GE Healthcare is recalling specific PET/MR imager models due to a potential electrical arc flash hazard within the Power Gradient & RF Cabinet.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a potential electrical arc flash, which is a significant injury hazard. Per the rubric, significant injury reports or risks warrant a Severe rating.

Plain-English summary

GE Healthcare, LLC is recalling specific models of Tomographic Imagers that combine Emission Computed Tomography (PET) with Nuclear Magnetic Resonance (MR). The affected units are identified by model numbers 5726207-8 and 5741000-28. These systems maintain independent functionality for MR and PET imaging.

The recall is being conducted because of a potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. This hazard presents a risk of electrical injury to personnel operating or maintaining the equipment.

The affected products were distributed worldwide, including nationwide distribution in the United States and in specific states such as FL, KY, NC, NJ, NM, NY, TX, UT, and WA. International distribution included Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico, and Uzbekistan. Healthcare facilities should contact GE Healthcare for instructions on how to address this safety issue.

The recalled product

Product: Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Imaging Equipment
Hazard: electrical-arc-flash

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Model: 5726207-8 and 5741000-28

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 5 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · GE Healthcare, LLC

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