Agency classClass IIOur severity:Severe FDA (Devices)·Z-3279-2018·Announced 2018-10-03

GE Medical Systems Recalls Discovery MR750w MRI Systems Due to Burn Risk

GE Medical Systems is recalling 516 Discovery MR750w MRI systems because a small area on the bore surface can become warm enough to cause a serious burn if a patient touches it without proper padding.

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 source text explicitly states the defect can cause a 'serious burn,' which aligns with the rubric criterion for 'significant injury' reports, warranting a score of 4 (Severe).

Plain-English summary

GE Medical Systems, LLC is recalling 516 units of the Discovery MR750w Nuclear Magnetic Resonance Imaging (MRI) System. The recall covers various model configurations, including the 3.0T MR750 32CH, 3.0T MR750W, and multiple GEM-enabled variants. These systems are distributed worldwide, including in the United States and numerous international countries.

The recall was initiated because GE Medical Systems discovered that a small area on the bore surface of the MRI system, which is normally accessible to the patient, can get warm enough to cause a serious burn. This hazard occurs if the patient touches the bore and proper padding is not used.

Healthcare facilities and users of these MRI systems should contact GE Medical Systems for instructions on how to address the issue. The source text does not specify a particular consumer action for the general public, as these are professional medical devices, but users should ensure proper padding is utilized to prevent patient contact with the affected area.

The recalled product

Product: Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C.…
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — MRI Scanner
Hazard: burn-injury
Affected units: 516

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 (20)

The following Product Name
Serial numbers and System IDs are associated with this recall. Product Name
Serial Number
(System ID)
A. 3.0T MR750 32CH
N/A
(HC1627MR04)
B. 3.0T MR750W
00001134FMM10P
(0910274040)
00001117FMMOCN
(PNUE08MR01)
00001204FMM054
(083027062157412)
00001236FMM04P
(EM0271)
00001308FMM05M
(EM0272)
00001308FMM04T
(EM0229)

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Same manufacturer · GE Medical Systems, LLC

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