Recall archive / FDA device enforcement
Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicin... — FDA record Z-1069-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 27, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- 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
- Classification
- Class II
- Recalling firm
- Mirion Technologies (Capintec), Inc.
- Quantity
- 467 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1069-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: 0859942006096 and 0859942006102 Serial Numbers: 940000 through 940535 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 21, 2024
- Recall initiation date
- Nov 27, 2023
- Center classification date
- Feb 9, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.