Food, drugs, devices › PTW-Freiburg
Device recall: PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therap
PTW-Freiburg (Freiburg, N/A) initiated this device recall on 27 May 2015; FDA lists 1 product record under event 71395, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 31 Mar 2017. Initiation: voluntary: firm initiated. PTW-Freiburg has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
PTW-Freiburg, Freiburg, N/A, Germany.
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."
Distribution
"Distributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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. | 242 firmwares | Class II | Terminated | 2 Sep 2015 |
Context
Other enforcement events for PTW-Freiburg
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 Feb 2024 | Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medic | Device | Class II | 1 |
| 7 Jun 2023 | BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is perform | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Mar 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.