Capintec, Inc.
United StatesFDA applicant, unverified
- Devices
- 14
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
What Capintec, Inc. makes
Capintec, Inc. manufactures dose calibrators—including the CRC 55T series (CRC 55TR, CRC 55TPET, CRC 55TW), CRC-15BT, CRC 25 series (CRC 25R, CRC 25PET, CRC 25W), and CRC-77tHR—for measuring radioactive doses in nuclear medicine. The company also produces electrometers (e.g., Model 292), well counters (CAPRA/CAPRAC-R), and systems for ambulatory ventricular evaluation (VEST) and radiopharmaceutical testing (CAP-RIA 16). Additional products include the CRC PC Smart Chamber K1 and the CARDIOLIGHT, a device for cardiac monitoring.
These devices are classified under FDA regulations as Class I or Class II, with relevant submissions recorded in the FDA’s 510(k) clearance database. The company is headquartered in the United States, and its products are subject to U.S. medical device regulations.
Catalogue
Search and filter all 14 devicesFDA recalls
FDA recall records list 6 recalls initiated by Capintec, Inc., the earliest on 2010-09-20 and the most recent on 2020-03-03. By recorded status: 6 terminated. The reasons filed fall into these groups: software or firmware and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 2
- 2019 0
- 2020 1
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2020
- 3 Mar 2020 Z-1564-2020 Class II Terminated 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.
Full distribution text
- 3 Mar 2020 Z-1564-2020 Class II Terminated 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.
2018
- 5 Nov 2018 Z-0550-2019 Class II Terminated There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground.
Full distribution text
- 5 Nov 2018 Z-0551-2019 Class II Terminated There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground.
Full distribution text
- 5 Nov 2018 Z-0550-2019 Class II Terminated There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground.
2012
- 24 Jul 2012 Z-2312-2012 Class II Terminated Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22, 1.23, 1.24, 1.25, and 1.26 may encounter an error while using the thyroid uptake protocol ?Measure Liquid and Subtract Residual." This protocol was a new feature added to Software Revision 1.22 in January 2011. The error occurs only if the user does NOT measure the residual dose immediately after me
Full distribution text
- 24 Jul 2012 Z-2312-2012 Class II Terminated Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22, 1.23, 1.24, 1.25, and 1.26 may encounter an error while using the thyroid uptake protocol ?Measure Liquid and Subtract Residual." This protocol was a new feature added to Software Revision 1.22 in January 2011. The error occurs only if the user does NOT measure the residual dose immediately after me
2011
- 8 Jul 2011 Z-0177-2012 Unclassified (pre-2012) Terminated Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET
Full distribution text
- 8 Jul 2011 Z-0177-2012 Unclassified (pre-2012) Terminated Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET
2010
- 20 Sep 2010 Z-0167-2011 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 20 Sep 2010 Z-0167-2011 Unclassified (pre-2012) Terminated 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.
Frequently asked questions
How many devices does Capintec, Inc. have in the registry?
The registry currently lists 14 devices for Capintec, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Capintec, Inc.'s devices?
Among its 14 most recently registered devices, Capintec, Inc. has devices listed in FDA 510(k) (14 devices).
What risk classes do Capintec, Inc.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Capintec, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Capintec, Inc.?
FDA recall records list 6 recalls initiated by Capintec, Inc., the most recent initiated on 3 Mar 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Capintec, Inc. in the registry?
The most recently registered devices listed for Capintec, Inc. include RADIATION TREATMENT PLANNING SYSTEM, CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW, CRC-15BT and 2 BASIC.