GE Healthcare recalls Innova IGS 630 X-ray system option that may lose imaging function if field of view is changed from 30cm to 20cm or vice versa while releasing the fluoroscopy pedal.
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 the Innova IGS 630 X-ray system option that may lose imaging function when changing field of view from 30cm to 20cm or vice versa while releasing the fluoroscopy pedal. This could affect medical procedures requiring precise imaging.
The system may lose x-ray imaging function when the user changes the field of view (FOV) from 30cm to 20cm or 20cm to 30cm while releasing the fluoroscopy footswitch pedal. This could lead to incomplete or inaccurate imaging during medical procedures.
Medical professionals using the Innova IGS 630 X-ray system option for cardiovascular and vascular procedures are most at risk. Patients undergoing these procedures may also be affected if the imaging function is lost.
Check for the model number 5503558 and system ID number 0850060757 on the Innova IGS 630 X-ray system option used in generating fluoroscopic and rotational images of human anatomy.
Ensure the field of view (FOV) is not changed from 30cm to 20cm or 20cm to 30cm while releasing the fluoroscopy footswitch pedal.
The system may lose x-ray imaging function when changing field of view from 30cm to 20cm or vice versa while releasing the fluoroscopy footswitch pedal.
Check for model number 5503558 and system ID number 0850060757 on the Innova IGS 630 X-ray system option.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1199-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1199-2019 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.
