GE Healthcare recalls Revolution CT systems with SmartStep Option that may scan at incorrect locations, risking inaccurate imaging. Affected units were sold between 2019 and 2:00 PM on 2023-01-01.
On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is not what was confirmed by the operator
GE Healthcare is recalling Revolution CT systems with the SmartStep Option because the Z location displayed may not match the actual table position, potentially causing inaccurate scans. This could lead to incorrect medical diagnoses if the system scans at the wrong location.
The SmartStep Option may display a Z location that doesn't match the actual table position. This can cause the CT scanner to scan at a location that wasn't confirmed by the operator, potentially leading to inaccurate medical images.
Healthcare facilities using Revolution CT systems with the SmartStep Option for medical imaging are most at risk. Patients undergoing scans with these systems could be affected if the system scans incorrectly.
Check if your Revolution CT system has the SmartStep Option. These systems were sold between 2019 and 2:00 PM on January 1, 2023.
Verify if your Revolution CT system has the SmartStep Option installed.
The SmartStep Option is a feature for Revolution CT systems that may display a Z location that doesn't match the actual table position.
Check if your Revolution CT system has the SmartStep Option installed. Affected units were sold between 2019 and 2:00 PM on January 1, 2023.
The recall does not specify a remedy, so contact GE Healthcare 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-0776-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0776-2019 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.
