FDA Device recall Z-0551-2019
Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
- FDA Device
- Class II
- terminated
- Published 2018-12-12
On 2018-12-12 the FDA classified a Class II recall of Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138 by Capintec, citing 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 downw….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0551-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-05 |
| Published | 2018-12-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Capintec |
| Distribution | US |
Product
Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
Reason
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.
Identifiers
| code_info | Serial Numbers 700004 through 700018. Serial Numbers 700019 through 700086 as of 1/15/19. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0551-2019%22
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