PTW-Freiburg recalls PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation thera…

Recall date

May 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2439-2015

FDA classification

Class II

Brand / firm

PTW-Freiburg

Sold / distributed

Distributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.