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CAPINTEC INC

CAPTUS 4000E · Gastroenterology and Urology

510(k): 0 Recall: 6 UDI: 3 MAUDE: 6 Class.: 0

Recalls (6)

2026-07-20

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.

2024-04-22

Complaints of unexpected detachment of the collimator have been reported.

2024-04-22

Complaints of unexpected detachment of the collimator have been reported.

2023-11-27

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

2020-03-03

It is possible that the collimators have screw hole locations that were insufficiently tapped. There is a potential for the collimator assembly to fall and come into contact with a patient or operator.

UDI Registrations (3)

Captus 4000e Thyroid Uptake System with 2 in well

The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module. This model includes a well counter with 2 inch of lead shielding.

Captus 4000e Thyroid Uptake System

The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module.

Captus 4000e Thyroid Uptake System with Well

The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, Bioassay module, Wipe Test Module, and Lab Tests.

MAUDE Adverse Events (6)

Malfunction
20231027
Malfunction
20231026
Malfunction
20230724
Malfunction
20230624
Malfunction
20200610
Malfunction
20190919