PTW UNIDOS webline: 1) REF T10023 — Class II medical device recall Z-2439-2015

Terminated recall by PTW-Freiburg, reported 2015-09-02, distributed in CA, MA, MI, NC, NJ, NY, PA, TN…. In some cases, especially with high dose-per-pulse-rates typical for particle (specifically proton) therapy, m

Recall number	`Z-2439-2015`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	PTW-Freiburg, Freiburg, N/A, Germany
Recall initiated	2015-05-27
Classified	2015-08-21
Reported by FDA	2015-09-02
Terminated	2017-03-31
Distributed	CA, MA, MI, NC, NJ, NY, PA, TN, TX, WI
Quantity	242 firmwares
Serial numbers	`000003`, `000005`, `000019`, `000022`, `000028`, `000037`, `000041`, `000046`, `000047`, `000049`, `000051`, `000058`, `000066`, `000074`, `000076`, `000079`, `000087`, `000096`, `000099`, `000106`, `000107`, `000118`, `000125`, `000138`, `000141` and 101 more
Model numbers	`T10022`, `T10023`

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2439-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.