GE Healthcare recalls Innova IGS 6 X-Ray Systems that may lose imaging function when switching 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 6 X-Ray System because changing the field of view from 30cm to 20cm or 20cm to 30cm while releasing the footswitch pedal simultaneously can cause the imaging function to fail. This could lead to inaccurate medical imaging during procedures.
The system may lose its x-ray imaging function when the user changes the field of view from 30cm to 20cm or 20cm to 30cm while simultaneously releasing the footswitch pedal. This could result in inaccurate medical images during procedures, potentially affecting patient care.
Healthcare providers using the Innova IGS 6 X-Ray System for medical procedures are most at risk if they operate the system without following the specific field of view change protocol.
Check for serial numbers starting with 501257IGS630, 951486RU630, 714993IGS630, or other listed combinations in the product description. The system was sold for medical procedures in the U.S. starting in 2018.
Ensure you do not change the field of view from 30cm to 20cm or vice versa while releasing the footswitch pedal simultaneously.
The recall includes specific serial numbers like 501257IGS630, 951486RU630, and others listed in the product description.
Check if your system has a serial number starting with 501257IGS630, 951486RU630, 714993IGS630, or other combinations listed in the product description.
No, but you must follow the specific field of view change protocol to avoid losing imaging function.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1201-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1201-2019 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.
