GE Medical MR Systems Patient Table Caster Locks May Not Have Been Checked
GE HealthCare is recalling 97 MR imaging systems worldwide because planned maintenance checks on patient table caster locks may not have been performed. Affected units include multiple SIGNA model variants used in medical imaging facilities.
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 Class II medical device recall involves safety-critical components on patient-facing equipment. Failure of caster locks could result in unexpected table movement and patient injury during imaging procedures. No injuries have been reported, but the risk to patient safety during medical procedures justifies High severity per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
GE HealthCare has issued a Class II recall of 97 MR imaging systems with worldwide distribution because planned maintenance steps to verify the caster locks on patient tables may not have been performed on certain units.
The affected systems include 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 their regional variants (AIR and XT models in China). All system ID numbers that received planned maintenance on or after March 1, 2023 are included in this recall.
The caster locks secure the patient table during movement and imaging procedures. If these safety-critical components have not been properly checked and maintained, they may not function correctly, potentially allowing the patient table to move unexpectedly during use. Medical facilities should contact GE HealthCare to arrange verification of caster lock functionality on affected equipment.
The recalled product
- Product
- GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- equipment-malfunction
- patient-safety-risk
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.
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