The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0983-2022·Announced 2022-04-27

GE Healthcare MRI Systems May Fall During De-Installation Without Proper Rigging

GE Healthcare MRI systems may fall during magnet de-installation if rigging and hardware are not properly installed and secured, creating a potential injury hazard.

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: This is an FDA Class II recall involving a potential fall hazard that could cause serious injury. However, no illnesses or injuries have been reported. Per the severity rubric, when hazards are theoretical with no reported harm, the score does not exceed 3.

Plain-English summary

GE Healthcare MRI systems are subject to a recall due to a fall hazard during the de-installation process. If all rigging and hardware that attach the magnet for transportation are not properly installed and secured, the magnet may fall, potentially causing injury to personnel.

The recall affects 18,411 GE Healthcare MRI systems that have been distributed worldwide, including throughout the United States, Puerto Rico, the U.S. Virgin Islands, and more than 100 countries internationally. Multiple models are affected, including the SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, SIGNA PET/MR, and numerous other variants.

This hazard specifically applies to the de-installation phase when the magnet is being removed and prepared for transport. The critical factor is proper installation and securing of all rigging and hardware components used to attach the magnet during removal. GE Healthcare has notified affected customers with detailed product identification information including serial numbers and unique device identifiers.

The recalled product

Product
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager…
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Magnetic Resonance Imaging (MRI)
Hazard
Affected units
18,411

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)

  • All GE Healthcare MR Systems. UDIs: 01008148480204781120092321QED3257
  • 01008148480204851119053021QED2493
  • 010088483808097321301223488
  • 010088483808097321301408170
  • (01)00846082115971(11)160923921)PG45
  • 01008148480200031117031321QED1184
  • 01008148480200031117052221QED1241
  • 01008148480200031117061221QED1268
  • 01008148480200031117082921QED1348
  • 01008148480200031118061521QED1775
  • 01008148480200031118072621QED1888
  • 01008148480200031118110721QED2090
  • 010081484802000311120010221QED2892
  • 010081484802000311120090121QED3227
  • 01008148480208071921QED1881
  • 01008148480202491118091321QED1990
  • 01008148480202491118110121QED2080
  • 01008148480202491119021421QED2282
  • 01008148480202491119022121QED2296
  • 01008148480202491119061321QED2525

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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