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U.S. Department of Health and Human Services

Class 2 Device Recall Captus 3000 Thyroid Uptake System with Portable Stand

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 Class 2 Device Recall Captus 3000 Thyroid Uptake System with Portable Standsee related information
Date Initiated by FirmSeptember 20, 2010
Date PostedOctober 28, 2010
Recall Status1 Terminated 3 on July 05, 2012
Recall NumberZ-0167-2011
Recall Event ID 56975
Product Classification Calibrator, dose, radionuclide - Product Code KPT
ProductCaptus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010. Manufactured by Capintec, Inc, Pittsburgh, PA.
Code Information Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010
FEI Number 2518443
Recalling Firm/
Manufacturer		 Capintec Inc
620 Alpha Dr
Pittsburgh PA 15238
For Additional Information ContactArt Hall
201-825-9500
Manufacturer Reason
for Recall		The spring arm on portable stand may have been over tightened during assembly, which may result in failure. If the spring arm fails, it will not balance the collimator weight, and the arm will drop to the lowest position.
FDA Determined
Cause 2		Employee error
ActionCapintec issued an Alert letter to all customers identifying the affected device, informing them of the problem and what actions are to be taken by customers. Capintec will send a replacement arm for the system, which is to be installed by the customer using included instructions. The firm included a correction acknowledgement form to be completed and returned by the customer. Customers can contact Capintec concerning this recall at 201 825-9500.
Quantity in Commerce9 units
DistributionWorldwide Distribution: USA in the states of NC and TN, and in the countries of Pakistan, Paraguay, Portugal, Saudi Arabia, and Spain.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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