GE Healthcare is recalling several MRI systems due to a risk of magnet falling during de-installation if hardware isn't properly secured, potentially causing injury. Affected models include SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery, and others. No remedy is specified in the recall notice.
During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.
GE Healthcare is recalling multiple MRI systems, including SIGNA Premier, SIGNA Architect, SIGNA Pioneer, and Discovery models, because if the magnet hardware isn't properly secured during de-installation, it could fall and cause injury. This recall does not include a specific remedy.
During the de-installation of an MRI system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall. This could lead to potential injury to people nearby.
Healthcare facilities and MRI system users who own or operate the recalled MRI systems are most at risk. The recall covers a wide range of GE Healthcare MRI models from 1.5T to 3.0T.
Check if your MRI system has a model number listed in the provided US System IDs or UDIs. The recall includes specific models like SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery, and many others with 1.5T and 3.0T capabilities.
Look for your MRI system's model number on the label or documentation to determine if it's affected by this recall.
The recall is happening because if the magnet hardware isn't properly secured during de-installation, the magnet may fall, leading to potential injury.
The recall notice does not specify any remedy. Affected users should check their model numbers to see if they are included in the recall.
Affected models include SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery, and many others with 1.5T and 3.0T capabilities, as listed in the US System IDs and UDIs provided in the recall notice.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0983-2022 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0983-2022 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.
