Mirion Technologies (Capintec), Inc.
3 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (3)
Devices registered here (1)
- Table, Operating-Room, Ac-PoweredProduct code FQO (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4960
Recalls & enforcement
- Class IIOngoing2026-07-20Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.
- Class IIOngoing2024-04-22Complaints of unexpected detachment of the collimator have been reported.
- Class IIOngoing2023-11-27Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury with a patient or operator
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Mirion Technologies (Capintec), Inc. (FEI 3042471748) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3042471748-mirion-technologies-capintec-inc/
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