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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Event Detail

Event ID 66724
Product Type Devices
Status Ongoing
Recalling Firm Siemens Medical Solutions USA, Inc
City Martinez
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-23
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution: USA (nationwide) including states of: FL, NC, NY, PA, TN, UT, and WI; and countries of: Angola, Brazil, Canada, P.R. China, Germany, India, Japan, Republic Korea, Poland, and Thailand.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, Roentgenstrasse 19-21, Kemnath, GERMANY 95478 and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA Serial Numbers: 5364, 5419, 5640, 5737, 5823, 5830, 5166, 5342, 5416, 5444, 5479, 5485, 5628, 5745, 5746, 5762, 5763, 5764, 5772, 5781, 5783, 5797, 5815, 5819, 5820, 5822, 5829, 5837, 5839, 5888, 5896, 5911, 5937 Class II SIEMENS became aware of two (2) customer complaints concerning a safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there are many long periods of field shape changes in a treatment plan, the dose due to dark current radiation may sum up to a significant value. 26 units Z-0438-2014
SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, Roentgenstrasse 19-21, Kemnath, GERMANY 95478 and distributed SIEMENS Healthcare IM CR RO, CR  Radiation Oncology, Martinez, CA. Serial Numbers: 5281, 5385, 5445 Class II SIEMENS became aware of two (2) customer complaints concerning a safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there are many long periods of field shape changes in a treatment plan, the dose due to dark current radiation may sum up to a significant value. 3 units Z-0437-2014
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