GE Medical Systems recalls certain SIGNA Architect AIR MRI systems sold in China due to potential failure in caster lock maintenance checks. Affected units were serviced after March 1, 2023. No immediate action is required but ensure maintenance checks are completed.
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 certain SIGNA Architect AIR MRI systems sold in China because planned maintenance checks for caster locks on the patient table may not have been performed. This could lead to the table moving unexpectedly during scans, potentially causing injury to patients or staff.
The caster locks on the MRI patient table may not have been properly checked during maintenance. If the locks fail, the table could move unexpectedly during a scan, potentially causing injury to patients or staff.
Patients and medical staff using the recalled SIGNA Architect AIR MRI systems in China are most at risk. The specific units affected are those serviced by GE HealthCare after March 1, 2023.
Check if your system has a GE HealthCare service date after March 1, 2023. The product is only available in China and has specific GTIN numbers listed in the recall notice.
Review your system's service records to confirm if GE HealthCare performed maintenance after March 1, 2023.
No, this recall is only for SIGNA Architect AIR systems sold in China.
No immediate action is required, but ensure maintenance checks are completed as per the recall.
Check your system's service records to confirm if maintenance was performed after March 1, 2023.
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-2312-2025 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2312-2025 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.
