• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.
Recall Number Z-1645-2014
Classification Class II
Code Info material #8139789 , 5857912, 7360717, 1940035, 8139789, 4504200, 5863472, serial # 5377, 5087, 70-4262, 5170, 5282 5506 3287 5527 5517 70-4378 3695 5364 5060 5205 5688 5743 70-4283 5190 5157 5343 5844 5148 5391 5300 70-4296 5474 70-4363 70-4368 3793 3817 5833 5899 5207 5355 70-4159 3524 5281 5894 5374 5558 3631 3835 5784 2765 5367 70-4354 70-4356 5540 5488 5590 5657 5350 5821 3413 5222 5843 5179 70-4129 5851 5098 5153 5700 5410 3825 5865 5118 5548 3769 5861 70-4188 5748 70-4317 5737 5830 5385 5656 3778 5088 5665 5823 5353 5630 5480 5096 5572 3873 5417 4059 5500 5388 70-4379 5226 5601 5640 5033 5177 5707 5398 4091 5532 70-4306 70-4161 5424 5755 5326 5145 5699 4079 4082 70-4077 70-4113 5525 5419 3975 5093 5481 5396 3089 5095 5154
Product Distributed Qty 120
Reason For Recall Table may lose calibration during patient treatment, which may cause the possibility of mistreatment.

Event Detail

Event Id 67957
Product Type Devices
Status Ongoing
Recalling Firm Siemens Medical Solutions USA, Inc
City Malvern
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA ( nationwide) Distribution.
-
-