GE Healthcare, LLC recalls VariCam

Recall date

October 30, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0704-2019

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Worldwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VariCam