Captus 4000e Thyroid Uptake System — Class II medical device recall Z-1564-2020
Terminated recall by Capintec Inc, reported 2020-04-01, distributed nationwide. It is possible that the collimators have screw hole locations that were insufficiently tapped. There is a pote
| Recall number | Z-1564-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Capintec Inc, Florham Park, NJ, United States |
| Recall initiated | 2020-03-03 |
| Classified | 2020-03-24 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2021-11-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BR, CA, CL, CO, CR, EC, ES, FR, GB, HK, IL, IN, IT, KR, MY, PH, PK, PL, SA, SE, TH, TR, TW, VN |
| Serial numbers | 940103, 940104, 940105, 940106, 940107, 940108, 940109, 940110, 940111, 940112, 940113, 940114, 940115, 940116, 940117, 940118, 940119, 940120, 940121, 940122, 940123, 940124, 940125, 940126, 940127 and 23 more |
| Model numbers | 5430-30151, 5430-30152 |
Product
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.
Reason for recall
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.
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-1564-2020. 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.