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.
Reported: September 2, 2015 Initiated: May 27, 2015 #Z-2439-2015
Product Description
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.
Details
- Recalling Firm
- PTW-Freiburg
- Units Affected
- 242 firmwares
- Distribution
- Distributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI.
- Location
- Freiburg, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by PTW-Freiburg. Units affected: 242 firmwares.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 2, 2015. Severity: Moderate. Recall number: Z-2439-2015.
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