Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine P
Summary
The FDA issued a Class II for Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medi by Mirion Technologies (Capintec), Inc.. Reason: Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potentia.
Details
Source
Device Recall
External ID
Z-1069-2024
Action Date
2024-02-21
Status
Ongoing
Category
device
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
Lot/Code Info: UDI: 0859942006096 and 0859942006102 Serial Numbers: 940000 through 940535
Quantity Affected: 467 units
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
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-27
Company
Florham Park, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Mirion Technologies (Capintec), Inc. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mirion Technologies (Capintec), Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mirion Technologies (Capintec), Inc. have FDA actions?
Mirion Technologies (Capintec), Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1069-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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