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Navigator 3 Wired Probe Cable

crystal-photonics GmbH · Model STERI-CABLE · UDI-DI 04260152884422

IZD
10
510(k) clearances
57
Adverse events
10
Recalls
34
Facilities

Description

gamma probe system, cable for wired probes

Recalls

DateFirmReason
2026-07-20Mirion Technologies (Capintec), Inc.Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.
2024-04-22Mirion Technologies (Capintec), Inc.Complaints of unexpected detachment of the collimator have been reported.
2024-04-22Mirion Technologies (Capintec), Inc.Complaints of unexpected detachment of the collimator have been reported.
2024-04-22Mirion Technologies (Capintec), Inc.Complaints of unexpected detachment of the collimator have been reported.
2023-11-27Mirion Technologies (Capintec), Inc.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 ope
2020-09-07Devicor Medical Products IncIt 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
2020-03-03Capintec IncIt 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
2018-11-05Capintec IncThere 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 downw
2018-11-05Capintec IncThere 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 downw
2012-07-24Capintec IncCustomers 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 p

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.