Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2439-2015 — 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.

U.S. FDA — Device Enforcement · Germany · 2015-05-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2439-2015
Date of alert: 2015-05-27
Country / jurisdiction: Germany
Risk level: Class II
Risk type: recall
Brand: PTW-Freiburg
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-2439-2015 — 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.

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