Captus 4000e Thyroid Uptake System with Well and 2 inch shielding — Class II medical device recall Z-1894-2024
Ongoing recall by Mirion Technologies (Capintec), Inc., reported 2024-06-05, distributed nationwide. Complaints of unexpected detachment of the collimator have been reported.
| Recall number | Z-1894-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mirion Technologies (Capintec), Inc., Florham Park, NJ, United States |
| Recall initiated | 2024-04-22 |
| Classified | 2024-05-24 |
| Reported by FDA | 2024-06-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BD, CA, CH, CL, CN, CR, DE, DZ, ES, FR, GB, HN, HR, HU, IL, IN, IT, JP, KR, LV, MY, NL, NZ, PH, PK, QA, RS, SA, SE, TH, TR, TW, VN, ZA |
| Quantity | 1,275 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00859942006423 |
| Model numbers | 5430-30154 |
Product
Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Reason for recall
Complaints of unexpected detachment of the collimator have been reported.
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-1894-2024. 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.