GE Healthcare recalls SIGNA MR355 and MR36: Cryogen ventilation systems may not meet venting requirements. Affected units require inspection by authorized personnel.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
GE Healthcare is recalling the SIGNA MR355 and SIGNA MR360 MRI systems because their cryogen ventilation systems might not meet safety standards. This could lead to unsafe conditions if the system is used without proper ventilation.
The cryogen ventilation system in these MRI systems may not meet required venting standards. This could result in inadequate ventilation of cryogenic fluids, potentially causing safety hazards if the system is not properly maintained.
Healthcare facilities using GE Healthcare SIGNA MR355 or SIGNA MR360 MRI systems are most at risk. The recall applies to all units sold.
Check for GE Healthcare SIGNA MR355 or SIGNA MR360 MRI systems. The recall applies to all units sold by the manufacturer.
Reach out to GE Healthcare for guidance on system inspection and potential remediation.
The recall does not require immediate discontinuation. Affected facilities should contact GE Healthcare for inspection guidance.
The cryogen ventilation system may not meet venting requirements, potentially leading to inadequate ventilation of cryogenic fluids.
Check if your MRI system is a GE Healthcare SIGNA MR355 or SIGNA MR360 model. The recall applies to all units sold.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0597-2022 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0597-2022 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.
