CLASS II Device recall · Reported 2 Sep 2015 · FDA Enforcement Report

PTW Unidos webline recalled by PTW-Freiburg

Ptw-Freiburg is recalling PTW Unidos webline, distributed in 10 states. The recall was initiated on 27 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesserial numbers: **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, 000711, 000731, 000752, 000756, 000763, 000785, 000792, 000793, 000796, 000800, 000820, 000829, 000830, 000857, 000860, 000863, 000865 ,000871, 000874, 000890, 000892, 000946, **T10022: 000003, 000046, 000066, 000087, 000096, 000106, 000118, 000138, 000172, 000178, 000183, 000186, 000188, 000210, 000240, 000317, 000336, 000347, 000350, 000351, 000358, 000360, 000392, 000398, 000420, 000422, 000425, 000434 -000453, 000456-000469, 000474, ** T10023: 000022, 000028, 000051, 00102, 000196, 000213, 000226, 000250, 000255, 000257, 000259, 000261, 000263, 000271, 000280, 000294

Quantity recalled242 firmwares

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2439-2015
FDA event ID: 71395
Recalling firm: Ptw-Freiburg, Freiburg, N/A
Classification: Class II
Status: Terminated
Recall initiated: 27 May 2015
FDA classified: 21 Aug 2015
Reported: 2 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

27 May 2015	Recall initiated by company
21 Aug 2015	Classified by FDA	+86 days
2 Sep 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Distributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI.

California Massachusetts Michigan North Carolina New Jersey New York Pennsylvania Tennessee Texas Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

serial numbers: **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, 000711, 000731, 000752, 000756, 000763, 000785, 000792, 000793, 000796, 000800, 000820, 000829, 000830, 000857, 000860, 000863, 000865 ,000871, 000874, 000890, 000892, 000946, **T10022: 000003, 000046, 000066, 000087, 000096, 000106, 000118, 000138, 000172, 000178, 000183, 000186, 000188, 000210, 000240, 000317, 000336, 000347, 000350, 000351, 000358, 000360, 000392, 000398, 000420, 000422, 000425, 000434 -000453, 000456-000469, 000474, ** T10023: 000022, 000028, 000051, 00102, 000196, 000213, 000226, 000250, 000255, 000257, 000259, 000261, 000263, 000271, 000280, 000294

Where was it sold?

Distributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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