Z-2439-2015Class II

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

Name: Z-2439-2015 PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for...
Creator: PTW-Freiburg
Published: 2015-05-27
License: https://open.fda.gov/license/

PTW-Freiburg / initiated 2015-05-27 / Terminated / root cause: software

FDA source

PTW-Freiburg began a recall of 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... on 2015-05-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2439-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-27
Posted: 2015-08-21
Terminated: 2017-03-31
Recalling firm: PTW-Freiburg
Product: 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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA 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 in commerce: 242 firmwares
Distribution: Distributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2439-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2439-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-21

Product code IYE

K951764Class IIUnidos Universal Dosimeter Model 10002-with Tnc Connector, 10005-with Bnt ConnectorPtw-New York Corp. / cleared 1995-10-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)