FDA Device recall Z-1564-2020
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medi…
- FDA Device
- Class II
- terminated
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medi… by Capintec, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1564-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-03 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Capintec |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Numbers: 940146 940124 940127 940134 940147 940110 940123 940117 940120 940105 940106 940115 940118…Serial Numbers: 940146 940124 940127 940134 940147 940110 940123 940117 940120 940105 940106 940115 940118 940136 940137 940114 940141 940142 940113 940148 940103 940121 940135 940150 940122 940128 940129 940109 940104 940119 940107 940145 940125 940126 940130 940131 940112 940149 940132 940108 940111 940116 940133 940144 940152 940153 940154 940155 Additional systems added as of 3/26/20: 940005 940065 940265 940317 940325 940370 940406 940514 940061 940368 940369 940375 940376 940484 940485 940486 940528 940200 940217 940522 940038 940044 940048 940059 940060 940066 940081 940084 940096 940151 940228 940229 940243 940271 940336 940337 940338 940355 940413 940431 940435 940451 940473 940300 940405 940148 940019 940020 940006 940435 940035 940145 940102 940157 940175 940261 940356 940358 940521 940164 940533 940189 940207 940314 940334 940386 940129 940062 940122 94021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1564-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.