Facility

MIRION TECHNOLOGIES (CAPINTEC), INC

3 recall(s) on record — most severe on record: Class II.

Key facts

3recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	2518443
Establishment type	Manufacture Medical Device
Location	7 Vreeland Rd Florham Park, NJ, US 07932
Registration status	Active · expires 2026
Parent company	Mirion Technologies, Inc. (owner-operator 10043529)
Brand names	Venti-Scan IV convenience Kit; Venti-Pak Convenience Kit for Venti-Scan VI; Venti-Scan IV

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (1)

System, Rebreathing, Radionuclide
Product code IYT (opens in a new tab) · Class II · Radiology · 21 CFR 892.1390

Recalls & enforcement

Class IIOngoing2026-07-20
Potential 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 IIOngoing2024-04-22
Complaints of unexpected detachment of the collimator have been reported.
Class IIOngoing2023-11-27
Spring 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

FDA inspections (1)

NAI2016-01-25
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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 2518443) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2518443-mirion-technologies-capintec-inc/

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