GE Medical Systems recalls certain SIGNA Premier Elite MRI systems sold in China due to potential failure in caster lock maintenance checks, which could affect patient safety during imaging procedures.
GE HealthCare has become aware that for certain MR systems (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, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
GE Medical Systems is recalling SIGNA Premier Elite MRI systems sold in China because planned maintenance checks for caster locks on the patient table may not have been completed. This could lead to the table moving unexpectedly during scans, posing a risk of injury to patients or staff.
The caster locks on the MRI patient table may not have been properly checked during planned maintenance. If the locks fail, the table could shift unexpectedly while a patient is being scanned, potentially causing injury.
Owners of SIGNA Premier Elite MRI systems sold in China since March 2023 are affected. Medical facilities using these systems for MRI scans are most at risk due to potential table movement during procedures.
Check if your system has a GE SIGNA Premier Elite model and was purchased in China since March 2023. The system ID numbers are listed in GE HealthCare's maintenance records.
Review your system's ID number to confirm it was maintained by GE HealthCare since March 1, 2023.
Reach out to GE HealthCare for guidance on whether your system requires additional maintenance checks.
GE HealthCare has identified that planned maintenance steps to check caster locks on the MRI patient table may not have been completed for certain systems, which could lead to unexpected movement during scans.
Your system is affected if it is a GE SIGNA Premier Elite model sold in China since March 2023, with a system ID number that GE HealthCare performed maintenance on.
No, but you should check if your system requires additional maintenance checks with GE HealthCare to ensure safety.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2314-2025 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2314-2025 from GE Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.