Drug recall
Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
FDA recall event 81605 · Class II · Capintec Inc
Key facts
| Event ID | 81605 |
|---|---|
| Recall numbers | Z-0550-2019, Z-0551-2019 |
| Recalling firm | Capintec Inc |
| Product type | Devices |
| Products | Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077, Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Nov 5, 2018 |
| Report date | Dec 12, 2018 |
| Termination date | Jun 30, 2020 |
| City | Florham Park |
| State | NJ |
| Country | United States |
| FEI number | 3000123149 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: