GE Healthcare recalls Innova IGS 630 X-Ray Systems that may lose imaging function when changing field of view from 30cm to 20cm or vice versa while releasing the footswitch pedal. Affected units have specific serial numbers.
There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.
GE Healthcare is recalling its Innova IGS 630 X-ray systems because changing the field of view from 30cm to 20cm or back while releasing the footswitch pedal can cause the imaging function to fail. This could lead to incomplete medical imaging during procedures.
When a user changes the field of view (FOV) from 30cm to 20cm or vice versa while simultaneously releasing the fluoroscopy footswitch pedal, the X-ray imaging function may temporarily stop working. This could result in incomplete medical imaging during procedures.
Healthcare providers using the Innova IGS 630 X-ray systems for medical procedures are most at risk. Patients undergoing imaging procedures with these systems may experience incomplete diagnostic results.
Check for specific serial numbers listed in the recall notice: 352333VASC3, 727869SPECIALS, 407518BIPLANE, 305227KBP630, and other model numbers listed in the record.
Look for the system serial number on the device or in the product documentation to confirm if it's affected.
Reach out to GE Healthcare directly for assistance with the recall and to confirm if your unit is affected.
The recall is due to a potential loss of X-ray imaging function when changing the field of view from 30cm to 20cm or vice versa while releasing the footswitch pedal simultaneously.
Check the system serial number against the list of affected units provided in the recall notice, which includes specific model numbers and serial numbers.
No, but users should be cautious when changing field of view settings to avoid imaging failures during procedures.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1200-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1200-2019 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.
