Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe…
Mirion Technologies (Capintec), Inc. · Complaints of unexpected detachment of the collimator have been reported.
Open FDA's page for this record- Cfres ID
- 207596
- Product res number
- Z-1894-2024
- Event date initiated
- 2024-04-22
- Event date posted
- 2024-05-24
- Recall status
- Open, Classified
- Res event number
- 94570
- Product code
- IZD
- 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.
- Code info
- Lot Code: Model No: 5430-30154; UDI 0859942006423; S/N range 940001 through 941398.
- Firm FEI number
- 2518443
- Recalling firm
- Mirion Technologies (Capintec), Inc.
- Address 1
- 7 Vreeland Rd
- City
- Florham Park
- State
- NJ
- Postal code
- 07932-1511
- Additional info contact
- Mitul Patel 201-8259500
- Reason for recall
- Complaints of unexpected detachment of the collimator have been reported.
- Root cause description
- Device Design
- Product quantity
- 1,275 units
- 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 capintecsupport@mirion.com. Consignees are also asked to confirm receipt of the notification utilizing the provided QR Code or form.
- Distribution pattern
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.
- Harmonized identifiers (openFDA)
- Device name
- Probe, Uptake, Nuclear
- Medical specialty description
- Radiology
- Regulation number
- 892.1320
- Device class
- 1
- K number
- K760595, K896540, K123917, K971167, K924586, K133781, K101887, K983768, K942580, K833140, K013751, K922117, K921428, K932153, K913055, K915279, K961321, K920115, K771301, K982442, K891466, K781742, K810006, K962319, K896588, K864263, K884770, K930962, K841440, K902460
- Registration number
- 3018094310, 3013875526, 3003508021, 3010027290, 3033043422, 1220477, 3008492462, 3010273872, 3029904425, 3009518669, 3013501110, 3008559295, 1219930, 3007200016, 2031874, 9611252, 3031564283, 1423929, 1222780, 3006051164, 2518443, 1836161, 3008962177, 2183613, 1125612, 3004636440, 3001556604, 8040278, 2020394, 8030607, 2080783, 3016852448, 8043980, 3034521
- FEI number
- 3018094310, 3013875526, 3002820546, 3003508021, 3002807720, 3010027290, 3033043422, 3002750084, 3008492462, 1220477, 3010273872, 3003350319, 3029904425, 3009518669, 1000120743, 3013501110, 3002931663, 3008559295, 1219930, 3007200016, 3031564283, 3006051164, 3006509795, 3004216008, 2518443, 3002914049, 3008962177, 2183613, 3004636440, 3001556604, 2020394, 3001451660, 2080783, 3016852448