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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Linear Accelerator (LINAC)

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 Class 2 Recall
Siemens Linear Accelerator (LINAC)
see related information
Date Posted May 23, 2014
Recall Status1 Open
Recall Number Z-1652-2014
Recall Event ID 67956
Premarket Notification
510(K) Number
K072485 
Product Classification Accelerator, Linear, Medical - Product Code IYE
Product Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
Code Information material numbers and serial numbers: 1940035 2962 8139789 5833 8139789 5899 9401654 2113 1940035 2628 4504200 3066 4504200 3361 1940035 3873 1940035 2855
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall
Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories which have not been validated as being compatible with Siemens LINAC models.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action Siemen sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Elekta representative.
Quantity in Commerce 9
Distribution US Nationwide Distribution in the states of AL, ME, PA, IL, and CA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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