FDA-Device2015-09-02Class II
PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
PTW-Freiburg
Hazard
In some cases, especially with high dose-per-pulse-rates typical for particle (specifically proton) therapy, measuring errors can result. Individual measurement intervals can be lost that are not visible to the user when there is a high dose-per-pulse rate resulting in a too-low dose being displayed on the monitor. This could result in a radiation over-exposure.
Sold states
Distributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI.
Affected count
242 firmwares
Manufactured in
Lorracher Strasse 7, N/A, Freiburg, N/A, Germany
Products
PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2439-2015Don't want to check this manually?
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