Capintec Recalls Captus 3000 Thyroid Uptake Systems Due to Spring Arm Failure
Capintec Inc is recalling 385 Captus 3000 Thyroid Uptake Systems because a broken tension rod can cause the spring arm to fail and the collimator to fall.
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 involves a mechanical failure that could cause a heavy component to fall, posing a risk of injury, but the source text does not report any actual injuries or illnesses.
Plain-English summary
Capintec Inc is recalling 385 units of the Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077. The affected units have serial numbers 901100 through 901309, and serial numbers 901310 through 901965 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 devices were distributed worldwide, including in the United States and various international locations. Users of these devices should contact Capintec Inc for further instructions on how to address the defect.
The recalled product
- Product
- Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
- Manufacturer
- Capintec Inc
- Affected units
- 385
Distribution
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 →Related recalls
Same manufacturer · Capintec Inc
See all →- HighCapintec Captus 4000e Thyroid Uptake System Recall for Collimator Defect
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FDA (Devices) · 2018-12-12
- ModerateCapintec Captus 3000 Thyroid Uptake System Software Error Recall
FDA (Devices) · 2012-09-12
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