GE Healthcare VariCam Medical Device Recall for Collimator Locking Handle Defect
GE Healthcare is recalling 64 VariCam units because a collimator locking handle defect may prevent the warning circuit from detecting an unlocked state during scans.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (unlocked collimator during scan) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
GE Healthcare, LLC is recalling 64 units of the VariCam medical device. The recall is due to a potential hazardous situation involving the collimator locking handle. If the handle is not properly placed in the lock position, the warning circuit may fail to detect that the collimator is unlocked, particularly when a patient is in close proximity to the collimator during a clinical scan.
The affected units were distributed worldwide. The recall includes specific serial numbers listed in the agency documentation. No specific dates of manufacture or distribution are provided in the source text.
Healthcare facilities should identify any affected VariCam units by checking the serial numbers against the provided list. Users should follow the instructions provided by GE Healthcare for the recall, which may involve stopping use of the device or implementing specific safety protocols to ensure the collimator is properly locked before scanning.
The recalled product
- Product
- VariCam
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 64
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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