High FDA (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.

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: 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: fall-hazard
rigging-failure
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:

Same manufacturer · GE Healthcare, LLC

See all →

High
GE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
High
GE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
High
GE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
High
GE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
High
SIGNA Premier MRI scanner recalled for elevated acoustic noise hazard
FDA (Devices) · 2022-07-27

Same hazard · fall hazard