Reported Sep 2, 2015 · Terminated

PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation…

PTW-Freiburg

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: PTW-Freiburg · Lorracher Strasse 7 · Freiburg, N/A · N/A

Is this the product you have?

  • PTW UNIDOS webline1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics
Lot codes and dates
  • serial numbers

    113 of 113 codes

    • **T10021: 000005
    • 000019
    • 000037
    • 000041
    • 000047
    • 000049
    • 000058
    • 000066
    • 000074
    • 000076
    • 000079
    • 000099
    • 000107
    • 000125
    • 000141
    • 000144
    • 000158
    • 000161
    • 000168
    • 000175
    • 000186
    • 000212
    • 000221
    • 000224
    • 000229
    • 000231
    • 000254
    • 000262
    • 000274
    • 000294
    • 000301
    • 000302
    • 000327
    • 000351
    • 000352
    • 000382
    • 000401
    • 000413
    • 000424
    • 000437
    • 000445
    • 000452
    • 000470
    • 000477
    • 000486
    • 000504
    • 000525
    • 000528
    • 000535
    • 000567
    • 000593
    • 000594
    • 000649
    • 000655
    • 000658
    • 000659
    • 000663
    • 000678
    • 000686
    • 000710
  • T10023
    • 000022
    • 000028
    • 000051
    • 00102
    • 000196
    • 000213
    • 000226
    • 000250
    • 000255
    • 000257
    • 000259
    • 000261
    • 000263
    • 000271
    • 000280
    • 000294
Amount recalled
242 firmwares

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new PTW-Freiburg recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 31, 2017 · Data as of Sep 19, 5:30 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.