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Completed

VariCam

FDA Recall Z-0704-2019 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusCompleted
Product CodeKPS
Date Initiated2017-10-30
Product Quantity64 units

Reason for Recall

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.

Firm Action

The firm initiated the medical device correction by letter on 10/0/2017. The letter instructed the consignee to ensure the collimator locking handles are in the locked position at all times. GE Healthcare will inspect and if necessary correct all affected products.

Root Cause

Other

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953801VARICAMElscint, Inc. · 1995-11-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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