GE Healthcare recalls Revolution CT with Apex Edition CT System for possible patient orientation errors during scans. Affected units have specific model and serial numbers. Contact GE for details.
A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
GE Healthcare is recalling its Revolution CT with Apex Edition CT System due to a risk of unintended patient orientation or scan settings when using Intelligent Protocoling. This could lead to incorrect medical imaging results if not properly managed.
The Intelligent Protocoling feature may cause the system to misalign patient orientation or apply incorrect scan settings during medical imaging. This could result in improper X-ray images that might not accurately represent the patient's condition.
Medical facilities using the Revolution CT with Apex Edition CT System for head, whole body, cardiac, or vascular X-ray imaging are affected. Patients undergoing scans with this system may be at risk of incorrect imaging results.
Check for model number 5995000-5 on the system. Serial numbers include REVVX1700078CN, 00000440315CN0, and REVVX1800040CN. The system was sold for head, whole body, cardiac, and vascular X-ray imaging.
Verify the model number is 5995000-5 to confirm if the system is affected.
The Intelligent Protocoling feature may cause unintended patient orientation or scan settings during X-ray imaging, potentially leading to incorrect medical images.
Check for model number 5995000-5 and serial numbers including REVVX1700078CN, 00000440315CN0, or REVVX1800040CN.
The recall does not specify a remedy, so contact GE Healthcare directly for guidance.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0695-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0695-2021 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.
