Recall Z-0550-2019 ยท IZD Probe, Uptake, Nuclear
Capintec Inc
Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
| Date | Dec 4, 2018 (initiated Nov 5, 2018) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Notification letters were sent to customers on 11/5/18. A Revised Product Alert - Corrective Action letter was sent to customers beginning 1/15/19 due to an expansion of the event. |
| Quantity | 385 |
| Distribution | Worldwide distribution - US nationwide distributed in the states of AR, AZ, CA, CO, CT, DC, FL, IA, IN, LA, MD, MI, MN, NC, NJ, OH, OK, PA, SC, SD, TX, VA, WI, WV, and countries of Argentina, Brazil, Canada, China, Cyprus, Greece, Hong Kong, India, Japan, South Korea, Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.