GE Healthcare recalls MR MAX System superconducting magnets due to potential cryogen ventilation system failures. This could lead to unsafe conditions in the imaging environment.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
GE Healthcare is recalling superconducting magnets used in their MR MAX System nuclear magnetic resonance imaging systems. The recall is because the cryogen ventilation system might not meet safety standards, which could create unsafe conditions in the imaging environment.
The cryogen ventilation system in these magnets might not meet required safety standards. This could lead to unsafe conditions in the imaging environment, but the risk is not immediately life-threatening.
Users of GE Healthcare MR MAX System imaging equipment. The risk is low for most users as the hazard involves potential ventilation issues rather than immediate danger.
The recalled items are GE Healthcare MR superconducting magnets, a component of the MR MAX System. All systems are affected, but specific model numbers or dates of sale are not provided in the recall notice.
Review the product label for the GE Healthcare MR MAX System model number to confirm if it is affected.
The recall states there is a potential issue with the cryogen ventilation system, but it does not specify that the hazard causes serious injury or death. The risk is considered low.
The recall does not require immediate discontinuation of use. The hazard is described as a potential issue that may not meet safety standards, but the risk is low.
The recall affects all GE Healthcare MR MAX System imaging equipment. Check the product label for the system model number to verify if it is included in the recall.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0619-2022 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0619-2022 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.
