Recall Z-2439-2015— PTW-Freiburg

Name: FDA recall Z-2439-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-27

Class II · Terminated

Class II FDA medical device recall by PTW-Freiburg, initiated 2015-05-27, terminated 2017-03-31. It names one FDA 510(k) clearance: K951764. 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.. Reason: 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..

Recalling firm: PTW-Freiburg
Classification: Class II
Status: Terminated
Initiated: 2015-05-27
Terminated: 2017-03-31
Firm location: Freiburg, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K951764 — UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTORPtw-New York Corp.·cleared 1995-10-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.