FDA Device recall Z-3193-2026
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154 by Mirion Technologies Capintec, citing potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3193-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-20 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Mirion Technologies Capintec |
| Distribution | US |
Product
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
Reason
Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.
Identifiers
| code_info | Affected Units: Captus 4000: 1. Model 5430-30151; UDI-DI: 00859942006096; 2. Model 5430-30152; UDI-DI: 00859942006102…Affected Units: Captus 4000: 1. Model 5430-30151; UDI-DI: 00859942006096; 2. Model 5430-30152; UDI-DI: 00859942006102; 3. Model 5430-30154; UDI-DI: 00859942006423; Devices shipped from April 2019 through February 2024, Serial Numbers 940548 through 941398, that have NOT already replaced the original arm with the redesigned arm. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Mirion Technologies Capintec
- Captus 4000e Thyroid Uptake System
FDA Device · Class II · 2024-06-05 · Mirion Technologies Capintec - Captus 4000e Thyroid Uptake System with Well and 2 inch shielding
FDA Device · Class II · 2024-06-05 · Mirion Technologies Capintec - Captus 4000e Thyroid Uptake System with Well
FDA Device · Class II · 2024-06-05 · Mirion Technologies Capintec - Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perfor…
FDA Device · Class II · 2024-02-21 · Mirion Technologies Capintec
All Mirion Technologies Capintec recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3193-2026%22
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