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U.S. Department of Health and Human Services

Class 2 Device Recall UNIDOS webline Universal Dosimeter

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 Class 2 Device Recall UNIDOS webline Universal Dosimetersee related information
Date Initiated by FirmMay 27, 2015
Date PostedAugust 21, 2015
Recall Status1 Terminated 3 on March 31, 2017
Recall NumberZ-2439-2015
Recall Event ID 71395
510(K)NumberK951764 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductPTW 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.
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
Recalling Firm/
Manufacturer		 PTW-Freiburg
Lorracher Strasse 7
Freiburg Germany
For Additional Information Contact
844-7894357
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionPTW 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 Commerce242 firmwares
DistributionDistributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IYE
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