Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-2439-2015 · Posted 2015-08-21

Recalling FirmPTW-Freiburg
Recall StatusTerminated
Product CodeIYE
Date Initiated2015-05-27
Date Terminated2017-03-31
Product Quantity242 firmwares

Reason for Recall

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.

Firm Action

PTW issues Urgent Safety Notice due to an error with firmware version 2.05 of the UNIDOS webline in some cases, especially with the high dose-per-pulse-rates typical for particle therapy, measuring errors can result.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K951764UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTORPtw-New York Corp. · 1995-10-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑