SIGNA PET/MR imager recalled over unconfirmed patient table caster lock checks
GE HealthCare is recalling 97 SIGNA PET/MR imagers because the planned maintenance step that checks the patient table caster locks may not have been performed.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers voluntary precautionary actions; the notice reports an unconfirmed maintenance step rather than a device defect, and no injuries.
Plain-English summary
GE HealthCare is recalling the SIGNA PET/MR, a tomographic imager combining emission computed tomography with nuclear magnetic resonance. The recall covers 97 units distributed worldwide, identified by GTIN numbers including 00195278648877, 00840682105378, 00840682123440 and 00840682135283.
GE HealthCare became aware that, for a group of MR systems that includes SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR and SIGNA Artist Evo, the planned maintenance steps that check the functionality of the caster locks on the MR patient table may not have been performed. The FDA classified the action as Class II.
Imaging sites operating an affected system should follow the manufacturer's instructions for having the caster lock check completed. GE HealthCare is contacting affected customers directly.
The recalled product
- Product
- GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI System
- Affected units
- 97
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 (7)
- GTIN: 00195278648877
- 00840682105378
- 00840682123440
- 00840682135283
- Not applicable
- Not available
- 2023
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 22 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 22 products in this recall →Related recalls
Same manufacturer · GE Medical Systems, LLC
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- HighGE Optima XR200/220/240amx Radiographic System Column Safety Mechanism
FDA (Devices) · 2026-07-22
- HighGE Medical Optima XR200/220/240amx Mobile Radiographic Systems Recall
FDA (Devices) · 2026-07-22
- HighGiraffe OmniBed incubator canopy fasteners can fall into patient compartment
FDA (Devices) · 2026-06-24
- HighGiraffe OmniBed replaceable units share the canopy fastener disengagement defect
FDA (Devices) · 2026-06-24
Same hazard · maintenance verification
See all →- ModerateSIGNA Artist Evo MRI recalled over unverified patient table caster lock checks
FDA (Devices) · 2025-08-20
- ModerateSIGNA Voyager AIR MRI recalled over unverified patient table caster lock maintenance
FDA (Devices) · 2025-08-20
- ModerateSIGNA Premier MRI system recalled over unconfirmed patient table caster lock maintenance
FDA (Devices) · 2025-08-20
- ModerateSIGNA Architect AIR MRI recalled over unverified patient table caster lock maintenance
FDA (Devices) · 2025-08-20
- ModerateDiscovery MR750 3.0T systems recalled over patient table caster lock maintenance gap
FDA (Devices) · 2025-08-20