FDA-Device2019-01-16Class II
VariCam
GE Healthcare, LLC
Hazard
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.
Sold states
Worldwide
Affected count
64 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
VariCam
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0704-2019Don't want to check this manually?
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