Class II — PTW-Freiburg
| Recalling firm | PTW Freiburg |
|---|---|
| Registered facility | PTW FREIBURG (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 242 firmwares |
| Distribution | Distributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI. |
| Initiated | 2015-05-27 |
| Classified | 2015-08-21 |
| Terminated | 2017-03-31 |
| Recall number | Z-2439-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PTW-Freiburg (Z-2439-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71395/
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