FDA Medical Device Recalls (openFDA)
PTW-Freiburg: 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.
- Recall number
- Z-2439-2015
- 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.
- Status
- Terminated
- Initiated
- 2015-05-27
- Posted
- 2015-08-21
- Terminated
- 2017-03-31
- Reason
- 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
- 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
- 242 firmwares
- Distribution
- Distributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K951764"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3007360740
- Firm city
- Freiburg
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28