FDA Device recall Z-1894-2024
Captus 4000e Thyroid Uptake System with Well and 2 inch shielding
- FDA Device
- Class II
- ongoing
- Published 2024-06-05
On 2024-06-05 the FDA classified a Class II recall of Captus 4000e Thyroid Uptake System with Well and 2 inch shielding by Mirion Technologies Capintec, citing complaints of unexpected detachment of the collimator have been reported.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1894-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-22 |
| Published | 2024-06-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Mirion Technologies Capintec |
| Distribution | US |
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
Complaints of unexpected detachment of the collimator have been reported.
Identifiers
| code_info | Lot Code: Model No: 5430-30154; UDI 0859942006423; S/N range 940001 through 941398. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1894-2024%22
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