Agency classClass IIOur severity:High FDA (Devices)·Z-2527-2018·Announced 2018-08-01

GE MR Surgical Suite Option Recalled for Patient Transfer Mechanism Defect

GE Medical Systems is recalling 54 MR Surgical Suite Option units because a defect in the table transfer release may cause an unexpected loss of function in the patient transfer mechanism.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where a mechanical failure could lead to injury, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

GE Medical Systems, LLC is recalling 54 units of the MR Surgical Suite Option, which is integrated with the GE Signa 3.0T or 1.5T magnetic resonance scanner. The recall is due to a potential safety issue with the table transfer release of the system.

The defect may cause an unexpected loss of function of the patient transfer mechanism, which is used to move patients from the GE MR Surgical Table to the Maquet Magnus Surgical Table. The affected units were distributed nationwide in the United States and internationally to various countries including Austria, Brazil, China, and the United Kingdom.

Healthcare facilities and consumers who possess these specific model numbers (M8074SS, M8053SS, M0074SS, M0001SS, 5265300-7, 5265300-8) should contact GE Medical Systems for instructions on how to resolve the issue. The recall number is Z-2527-2018.

The recalled product

Product: MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution high signal-to-noise…
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — Imaging Equipment
Hazard: mechanical-failure
patient-transfer-defect
Affected units: 54

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)

Model Numbers M8074SS
M8053SS
M0074SS
M0001SS
5265300-7
5265300-8. Serial Number (System ID Number): 00000000000002 (602406IMR)
4295404 (4295404MR11)
N/A (415UCBHMR3)
N/A (720848MR4)
00000304124MR1 (904202MR8)
N/A (309655IMRI)
4425007 (913588NMRW)
00000000UA0117 (616267IMRI)
00000000000003 (507284NMRV)
4311497 (MR229054)
4510086 (212636SIGNA3T)
00000000UA0116 (330344MR750W)
UA0326 (614293MR9)
N/A (614RMHTMR1)
4371613 (412692MR750W)

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Same manufacturer · GE Medical Systems, LLC

See all →

High
Mobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
High
GE Optima XR200/220/240amx Radiographic System Column Safety Mechanism
FDA (Devices) · 2026-07-22
High
GE Medical Optima XR200/220/240amx Mobile Radiographic Systems Recall
FDA (Devices) · 2026-07-22
High
Giraffe OmniBed incubator canopy fasteners can fall into patient compartment
FDA (Devices) · 2026-06-24
High
Giraffe OmniBed replaceable units share the canopy fastener disengagement defect
FDA (Devices) · 2026-06-24

Same hazard · mechanical failure