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WPROBE
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA · Model STD · UDI-DI 08437018413072
IZD
Prescription
10
510(k) clearances
55
Adverse events
9
Recalls
34
Facilities
Description
GAMMAPRO is a wireless ionizing radiation detector probe for use in the medical environment. The instrument is optimized to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity. GAMMAPRO is comprised of the probe and the software installed in a control unit that is compatible with its use. GAMMAPRO is presented in 4 models: normal (GAMMAPRO STD), High Sensitivity (GAMMAPRO Hi-S), laparoscopic (GAMMAPRO LAP model) and ANGLED (GAMMAPRO ANG).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-22 | Mirion Technologies (Capintec), Inc. | Complaints of unexpected detachment of the collimator have been reported. |
| 2024-04-22 | Mirion Technologies (Capintec), Inc. | Complaints of unexpected detachment of the collimator have been reported. |
| 2024-04-22 | Mirion Technologies (Capintec), Inc. | Complaints of unexpected detachment of the collimator have been reported. |
| 2023-11-27 | Mirion 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 |
| 2020-09-07 | Devicor Medical Products Inc | 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 |
| 2020-03-03 | Capintec Inc | 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 |
| 2018-11-05 | Capintec Inc | 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 downw |
| 2018-11-05 | Capintec Inc | 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 downw |
| 2012-07-24 | Capintec Inc | 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 p |
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Get your free API keyRead the docsData 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.