GE Medical Systems recalls certain SIGNA PET/MR AIR Plus MRI systems sold in China due to potential failure in caster lock maintenance steps, 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 specific SIGNA PET/MR AIR Plus MRI systems sold in China because planned maintenance checks for the patient table's caster locks may not have been completed. This could lead to the table moving unexpectedly during scans, potentially causing injury to patients or staff.
The patient table's caster locks may not have been properly checked during planned maintenance, which could cause the table to shift unexpectedly during MRI scans. This shift might result in injury to patients or medical personnel if the table moves while the patient is being scanned.
Patients and medical staff using the recalled SIGNA PET/MR AIR Plus MRI systems in China are at risk if the patient table's caster locks fail during imaging. The risk is highest for those who have recently had maintenance performed on the system since March 2023.
Check if your system has a GE SIGNA PET/MR AIR Plus model and was sold in China. Look for system IDs that GE HealthCare performed maintenance on since March 1, 2023.
Identify your system ID to confirm if it was maintained by GE HealthCare since March 1, 2023.
Reach out to GE Medical Systems for guidance on whether your system requires additional maintenance steps.
GE HealthCare has found that planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been completed for certain systems, which could lead to unexpected movement during scans.
The recall indicates a potential risk of the patient table shifting during scans, which could cause injury. However, the specific hazard severity is not described as causing death or serious injury in normal use.
Check if your system is a GE SIGNA PET/MR AIR Plus model sold in China and if it has a system ID that GE HealthCare performed maintenance on since 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-2320-2025 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2320-2025 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.