Recall Z-0704-2019— GE Healthcare, LLC

Name: FDA recall Z-0704-2019
Creator: U.S. Food and Drug Administration
Published: 2017-10-30

Class II · Completed

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2017-10-30. It names one FDA 510(k) clearance: K953801. Product: VariCam. Reason: 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Completed
Initiated: 2017-10-30
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K953801 — VARICAMElscint, Inc.·cleared 1995-11-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VariCam

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.