GE Healthcare recalls Revolution Apex and Revolution CT with Apex Edition models 5995000-5 for potential smudge artifacts that could affect medical imaging accuracy.
There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
GE Healthcare is recalling specific models of their Revolution Apex and Revolution CT scanners due to a potential smudge artifact in images that could lead to incorrect medical diagnoses. This issue affects the scanner's ability to produce accurate images for head, body, cardiac, and vascular X-ray CT scans.
The scanner's settings may cause smudge artifacts in some medical images, which could lead to incorrect pathology detection. This is a technical issue with image processing that might affect diagnostic accuracy but does not cause physical harm.
Medical facilities using the recalled Revolution Apex and Revolution CT with Apex Edition models (5995000-5) are most at risk. Patients undergoing scans with these models may see inaccurate images.
Check for the model number 5995000-5 on the scanner. The lot/serial numbers listed in the recall include codes starting with REVVX, REV2A, or DUMFMI followed by numbers and CN.
Identify the model number on your scanner; the recalled units have model 5995000-5.
Reach out to GE Healthcare for further guidance on the recall and potential remedies.
The recalled model is 5995000-5 for Revolution Apex and Revolution CT with Apex Edition.
Check the model number on your scanner; affected units have model 5995000-5 and specific lot/serial numbers listed in the recall.
The recall record does not specify a remedy, so no immediate fix is provided.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0306-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0306-2021 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.
