Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff
Summary
The FDA issued a Class II for Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to b by Mirion Technologies (Capintec), Inc.. Reason: Complaints of unexpected detachment of the collimator have been reported..
Details
Source
Device Recall
External ID
Z-1894-2024
Action Date
2024-06-05
Status
Ongoing
Category
device
Product Description
Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Lot/Code Info: Lot Code: Model No: 5430-30154; UDI 0859942006423; S/N range 940001 through 941398.
Quantity Affected: 1,275 units
Reason for Recall
Complaints of unexpected detachment of the collimator have been reported.
Distribution
Worldwide - US Nationwide distribution and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BANGLADESH, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, FRANCE, GERMANY, GUAM, HONDURAS, HUNGARY, INDIA, ISRAEL, ISREAL, ITALY, JAPAN, KOREA, LATVIA, MALAYSIA, NETHERLANDS, NEW ZEALAND, PAKISTAN, PHILIPPINES, PHILIPPINES , PHILLIPINES, PUERTO RICO, QATAR, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TAIWAN , THAILAND, TURKEY, UNITED KINGDOM, VIETNAM.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-22
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 258 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-1894-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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