Recall Z-2439-2015 ยท IYE Accelerator, Linear, Medical
PTW-Freiburg
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.
| Date | Aug 21, 2015 (initiated May 27, 2015) |
| 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. |
| Root cause | Software design |
| 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. |
| Quantity | 242 firmwares |
| Distribution | Distributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951764 | UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR Ptw-New York Corp., Oct 7, 1995 |