The Recall Desk
HighFDA (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.

What this means for you

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 ra
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Imaging Equipment
Hazard
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:

Related recalls

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Same hazard · mechanical failure

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