Discover VH/Millennium VG Nuclear Medicine Imaging System
FDA Recall Z-0703-2019 · Posted None
Recalling FirmGE Healthcare, LLC
Recall StatusCompleted
Product CodeKPS
Date Initiated2017-10-30
Product Quantity339 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.