PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therap
FDA device recall Z-2439-2015 · posted 2015-08-21 · Terminated
Recall details
- Recalling firm
- PTW-Freiburg
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 242 firmwares
- Distribution
- Distributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI.
- Date initiated
- 2015-05-27
- Date posted
- 2015-08-21
- Date terminated
- 2017-03-31
- Location
- Freiburg, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR (K951764) | Ptw-New York Corp. | 1995-10-07 |