Recall Z-1564-2020 ยท IZD Probe, Uptake, Nuclear
Capintec Inc
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
| Date | Mar 24, 2020 (initiated Mar 3, 2020) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Important Captus 4000e Safety Notice, Action Required letters dated 3/3/20 were sent to customers. As a precautionary measure, Capintec is requesting customers, whose systems include collimators from the same batch, perform a simple safety inspection. A detailed and easy to follow inspection procedure is included. The inspection can be performed in a few minutes, and any defect would be easily identified. Please confirm completion of inspection process by completing the attached form (page 2) and return to Capintec, Inc. For additional assistance or information, email capintec.techsupport@cap |
| Quantity | 48 (481 additional units added 3/26/20) |
| Distribution | Worldwide distribution. US Nationwide, Australia, Austria, Bangladesh, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, France, Hong Kong, India, Israel, Italy, Korea, Malaysia, Pakistan, Philippines, Poland, Saudi Arabia, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, UK, and Vietnam. (list u |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.