Captus 3000 Thyroid Uptake System — Class II medical device recall Z-0550-2019
Terminated recall by Capintec Inc, reported 2018-12-12, distributed nationwide. There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the ar
| Recall number | Z-0550-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Capintec Inc, Florham Park, NJ, United States |
| Recall initiated | 2018-11-05 |
| Classified | 2018-12-04 |
| Reported by FDA | 2018-12-12 |
| Terminated | 2020-06-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BR, CA, CN, CY, GR, HK, IN, JP, KR, VN |
| Quantity | 385 |
| Reason classes | device malfunction |
| Serial numbers | 901100, 901310 |
| Model numbers | 5430-0076, 5430-0077 |
Product
Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
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 point of travel, approximately 25 inches from the ground.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0550-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.