Z-2439-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2015
- Initiation Date
- May 27, 2015
- Termination Date
- March 31, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 242 firmwares
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.
Distribution Pattern
Distributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI.
Code Information
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