GE Healthcare recalls VariCam devices with specific serial numbers due to potential safety risk if collimator locking handle isn't properly secured during clinical scans.
A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan.
GE Healthcare is recalling certain VariCam devices because if the collimator locking handle isn't properly placed in the lock position, the device might not detect the patient's proximity, creating a potential safety hazard during scans. This could lead to unsafe conditions if the device isn't correctly secured.
The collimator locking handle must be correctly positioned to ensure the warning circuit detects if the collimator is unlocked. If the handle isn't properly locked, the device might not detect patient proximity during scans, potentially causing unsafe conditions.
Medical professionals using the VariCam devices for clinical scans are most at risk, particularly those who may not properly secure the collimator locking handle during procedures.
Check for serial numbers listed in the recall notice: 0000000010-203, 0000000010-191, and other specific numbers provided in the official recall list.
Identify the serial number on your VariCam device to see if it matches the list of recalled serial numbers provided in the recall notice.
The recall is due to a potential safety risk where the collimator locking handle might not be properly secured, causing the device to fail to detect patient proximity during scans.
Check your device's serial number against the list of recalled serial numbers provided in the recall notice. If it matches, you should contact GE Healthcare for further instructions.
The recall record does not specify a remedy, so no immediate fix is provided. Affected users should 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-0704-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0704-2019 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.
