GE Healthcare recalls Innova IGS 3, 5, and 6 x-ray systems with a vertical line defect that splits monitor images. Affected units have specific serial numbers listed in the recall notice.
The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen.
GE Healthcare is recalling certain Innova IGS 3, 5, and 6 interventional fluoroscopic x-ray systems due to a vertical line defect that splits monitor images. This defect could cause inaccurate imaging during medical procedures.
The defect causes a single vertical line to divide the monitor screen, shifting live images into two unequal parts. This could lead to misdiagnosis or incorrect treatment decisions during medical procedures.
Medical facilities using the affected Innova IGS 3, 5, or 6 x-ray systems are most at risk. Patients undergoing procedures with these systems may see inaccurate imaging.
Check the serial numbers listed in the recall notice. Affected units include specific models (Innova IGS 3, 5, 6) with serial numbers starting with B2-, B3-, D3-, D4-, M2-, or M3-.
Compare your system's serial number against the list of affected serial numbers provided in the recall notice.
Innova IGS 3, Innova IGS 5, and Innova IGS 6 interventional fluoroscopic x-ray systems with specific serial numbers listed in the recall notice.
The system shows a single vertical line that divides the monitor screen, causing live images to shift into two unequal parts.
No action is required if your system's serial number is not listed 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-1864-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1864-2021 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.
