GE Healthcare recalls SIGNA Voyager and Premier Edition MRI magnets due to potential cryogen ventilation system failure. Affected units may require repair or replacement to prevent safety risks.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
GE Healthcare is recalling the superconducting magnets used in SIGNA Voyager and SIGNA Voyager Premier Edition MRI systems because their cryogen ventilation systems might not meet safety standards. This could lead to safety issues if the system is not properly maintained.
The cryogen ventilation system in these MRI magnets might not meet required safety standards. This could cause the system to fail, potentially leading to safety hazards if the magnet is not properly maintained.
MRI system users and healthcare facilities that own SIGNA Voyager or SIGNA Voyager Premier Edition systems. Patients and staff are at risk if the magnet's ventilation system fails.
The affected items are the superconducting magnets used in GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition MRI systems. All units are included in this recall.
Identify if your MRI system is a SIGNA Voyager or SIGNA Voyager Premier Edition model.
The cryogen ventilation system in these MRI magnets might not meet required safety standards, which could lead to system failures.
The recall does not specify a remedy, so contact GE Healthcare directly for guidance.
The recall states potential safety issues but does not specify injury risks.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0599-2022 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0599-2022 from GE Healthcare. 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.