The Recall Desk
HighFDA (Devices)·Z-0551-2019·Announced 2018-12-12

Capintec Recalls Captus 700 Thyroid Uptake Systems Due to Spring Arm Failure

Capintec Inc is recalling 65 Captus 700 Thyroid Uptake Systems because a broken tension rod can cause the spring arm to fail and the collimator to fall.

What this means for you

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 involves a risk-of-harm product where a mechanical failure could cause the device to fall, but the source text does not report any injuries or illnesses.

Plain-English summary

Capintec Inc is recalling 65 units of the Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138. The recall affects serial numbers 700004 through 700018, and serial numbers 700019 through 700086 as of January 15, 2019.

The recall is due to a potential spring arm failure caused by a broken tension rod, a component inside the arm. If the tension rod breaks, the collimator can fall downward to its lowest point of travel, which is approximately 25 inches from the ground.

The affected devices were distributed worldwide, including nationwide in the United States and in specific countries such as Argentina, Brazil, Canada, China, Cyprus, Greece, Hong Kong, India, Japan, South Korea, and Vietnam. Users should contact Capintec Inc for further instructions regarding the recall.

The recalled product

Product
Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
Manufacturer
Capintec Inc
Affected units
65

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Capintec Inc 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.

See all 2 products in this recall →