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
Reported: February 21, 2024 Initiated: November 27, 2023 #Z-1069-2024
Product Description
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
Reason for Recall
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
Details
- Recalling Firm
- Mirion Technologies (Capintec), Inc.
- Units Affected
- 467 units
- Distribution
- Nationwide Foreign: AUSTRIA BANGLADESH BRASIL Brazil CANADA CHILE Costa Rica Ecuador France Hanoi Vietnam Hong Kong INDIA ISRAEL ITALY Malaysia PAKISTAN Philippines POLAND Saudi Arabia SOUTH KOREA Spain SWEDEN TAIWAN THAILAND TURKEY UNITED ARAB EMIATES UNITED KINGDOM VIETNAM
- Location
- Florham Park, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Mirion Technologies (Capintec), Inc.. Units affected: 467 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 21, 2024. Severity: Moderate. Recall number: Z-1069-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11