Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1069-2024 — Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154

U.S. FDA — Device Enforcement · United States · 2023-11-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1069-2024
Date of alert
2023-11-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Mirion Technologies (Capintec), Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0859942006096
Reported risk: Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury with a patient or operator
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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