Z-1894-2024Class II

Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid...

Name: Z-1894-2024 Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid...
Creator: Mirion Technologies (Capintec), Inc.
Published: 2024-04-22
License: https://open.fda.gov/license/

Mirion Technologies (Capintec), Inc. / initiated 2024-04-22 / Open, Classified / root cause: design

FDA source

Mirion Technologies (Capintec), Inc. began a recall of Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests on 2024-04-22. FDA classified it as Class II and gives the reason as "Complaints of unexpected detachment of the collimator have been reported". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1894-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-22
Posted: 2024-05-24
Recalling firm: Mirion Technologies (Capintec), Inc.
Product: Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Product code: IZD Probe, Uptake, Nuclear
Reason for recall: Complaints of unexpected detachment of the collimator have been reported.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were sent an URGENT SAFETY NOTICE via email, dated 4/1/24. Consignees are asked to review the provided notice, share the notice with ass affected personnel, instruct personnel to comply with the provided instructions for safe operation and how to perform a retention plate inspection, and to contact Capintec Technical Support if the inspection shows that the collimator is not properly attached. Capintec Technical Support can be reached by phone at 1-800-631-3826 or at 1-201-825-9500, or by email at [email protected]. Consignees are also asked to confirm receipt of the notification utilizing the provided QR Code or form.
Quantity in commerce: 1,275 units
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.
Product codes and lots: Lot Code: Model No: 5430-30154; UDI 0859942006423; S/N range 940001 through 941398.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1894-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1892-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-24
Z-1893-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-24
Z-1894-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-24

Product code IZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)