Probe, Uptake, Nuclear
Radiology · 21 CFR 892.1320
Recent MDR events
55 adverse event reports on file
- TRUNODE SURGICAL GAMMA PROBEJul 7, 2026MalfunctionHologic, Inc.1222780-2026-00423
- TRUNODE SURGICAL GAMMA PROBEJun 16, 2026MalfunctionHologic, Inc.25518011
- TRUNODE SURGICAL GAMMA PROBEJun 10, 2026InjuryHologic, Inc.1222780-2026-00350
- TRUNODE SURGICAL GAMMA PROBESep 5, 2025MalfunctionHologic, Inc.22977081
- TRUNODEMar 6, 2025MalfunctionHologic, Inc21535068
- TRUNODEFeb 18, 2025InjuryHologic, Inc1222780-2025-00082
- TRUNODEFeb 18, 2025InjuryHologic, Inc1222780-2025-00081
- TRUNODEFeb 18, 2025InjuryHologic, Inc1222780-2025-00079
- TRUNODEFeb 18, 2025InjuryHologic, Inc1222780-2025-00083
- TRUNODEFeb 18, 2025InjuryHologic, Inc1222780-2025-00080
Event type breakdown
Recalls
9 recall events for this product code
- Mirion Technologies (Capintec), Inc.Open, ClassifiedMay 24, 2024
Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Complaints of unexpected detachment of the collimator have been reported.
Z-1892-2024 · View FDA record ↗ - Mirion Technologies (Capintec), Inc.Open, ClassifiedMay 24, 2024
Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Complaints of unexpected detachment of the collimator have been reported.
Z-1893-2024 · View FDA record ↗ - Mirion Technologies (Capintec), Inc.Open, ClassifiedMay 24, 2024
Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Complaints of unexpected detachment of the collimator have been reported.
Z-1894-2024 · View FDA record ↗ - Mirion Technologies (Capintec), Inc.Open, ClassifiedFeb 9, 2024
Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Proc
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
Z-1069-2024 · View FDA record ↗ - Capintec IncTerminatedMar 24, 2020
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or
It is possible that the collimators have screw hole locations that were insufficiently tapped. There is a potential for the collimator assembly to fall and come into contact with a patient or operator.
Z-1564-2020 · View FDA record ↗ - Capintec IncTerminatedDec 4, 2018
Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground.
Z-0550-2019 · View FDA record ↗ - Capintec IncTerminatedDec 4, 2018
Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground.
Z-0551-2019 · View FDA record ↗ - Capintec IncTerminatedSep 5, 2012
Capintec Captus 3000 Thyroid Uptake System
Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22, 1.23, 1.24, 1.25, and 1.26 may encounter an error while using the thyroid uptake protocol ?Measure Liquid and Subtract Residual." This protocol was a new feature added to Software Revision 1.22 in January 2011. The error occurs only if the user does NOT measure the residual dose immediately after me
Z-2312-2012 · View FDA record ↗ - Devicor Medical Products IncTerminatedUnknown
Neoprobe GDS Control Unit, Model Number NPCU3
It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.
Z-0070-2021 · View FDA record ↗
Registered firms
36 firms currently registered for this product code
Mirion Technologies (capintec), Inc
Florham Park, NJ, US
Dilon Technologies Inc
NEWPORT NEWS, VA, US
Radnostix
IDAHO FALLS, ID, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Bard Peripheral Vascular, Inc.
TEMPE, AZ, US
Synergy Health Ast, Srl
Alajuela, CR
Covidien
North Haven, CT, US
Eurorad Deux Six
ECKBOLSHEIM Bas-Rhin, FR
Hologic, Inc.
Marlborough, MA, US
Novanta Medical S.r.o.
Prelouc Pardubicky Kraj, CZ
Nihon Kohden Corporation - Tokorozawa Establishment Advanced Technology Center
Tokorozawa Saitama, JP
Southern Scientific Ltd
Henfield West Sussex, GB
Tricor Systems
ELGIN, IL, US
Modo Inc.
Tualatin, OR, US
Nortech Systems, Inc.
Milaca, MN, US
Nihon Kohden America, Inc.
Irvine, CA, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Isomedix Operations Inc.
Northborough, MA, US
Clerad
Clermont-Ferrand Puy-de-Dome, FR
Volgo Care International (private) Limited
Sialkot Punjab, PK
Novanta Medical Gmbh
LUDWIGSSTADT Bavaria, DE
Riverside Medical Packaging Company Ltd
Derby Derbyshire, GB
General Equipment For Medical Imaging, S.a.
Valencia, ES
Lightpoint Surgical Limited
AMERSHAM Hertfordshire, GB
Modo Inc
Hillsboro, OR, US
510(k) clearances
30 clearances for this product code
- Surgiceye GmbHApr 11, 2014
K133781 · DECLIPSESPECT LAPAROSCOPY
- Surgiceye GmbHJan 25, 2013
K123917 · DECLIPSESPECT VIEWER
- Surgiceye GmbHMar 22, 2011
K101887 · CONFIDENT SURGERY SUITE 300, MODEL CSS300
- Silicon Instruments GmhbFeb 6, 2002
K013751 · HANDHELD GAMMA FINDER (HGF)
- Radiation Monitoring Devices, Inc.Jul 2, 1999
K983768 · MODIFICATION TO GAMMA GUIDANCE SYSTEM
- Care Wise Medical Products Corp.Aug 25, 1998
K982442 · C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)
- Neoprobe Corp.Jun 26, 1997
K971167 · NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES
- Radiation Monitoring Devices, Inc.Feb 10, 1997
K961321 · GAMMA GUIDANCE SYSTEM