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PTW-Freiburg recalls PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therap
Recalled September 2, 2015 · FDA recall Z-2439-2015 · 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. · FDA Class II
Units
242 firmwares
Sold at
Distributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI.
Description
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.
Product
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.
Manufacturer(s)
PTW-Freiburg
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →