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U.S. Department of Health and Human Services

Class 2 Device Recall ONCOR IMPRESSION Plus

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  Class 2 Device Recall ONCOR IMPRESSION Plus see related information
Date Initiated by Firm December 10, 2007
Date Posted September 29, 2008
Recall Status1 Terminated 3 on May 13, 2011
Recall Number Z-1760-2008
Recall Event ID 47226
510(K)Number K060226  
Product Classification Linear Accelerator - Product Code IYE
Product Siemens Medical Solutions, ONCOR IMPRESSION Plus Digital Linear Accelerator, part number 5857912 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.
Code Information Serial Number: 3894 
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information Contact
925-246-8407
Manufacturer Reason
for Recall
Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.
FDA Determined
Cause 2
Device Design
Action Siemens sent a Customer Safety Advisory Notice dated 12/12/2007 to DEVA customers. The letter stated that Siemens would temporarily disable energies 5MeV and below for all customers that decide to continue using the DEVA, resulting in the temporary unavailability of energies 5MeV and below for all available. Customers wishing not to have these energies blocked must return their DEVA and they would be contacted by a local Siemens rep to schedule a service appointment. The letter stated that as a preventative measure that those customers should refrain from using the DEVA with any combination of energies 5MeV and below with field sizes smaller than 6cm x 6cm. The firm suggested using the fixed field electron applicators and cutouts with these energies and field sizes. Siemens will release a new control console software in 2008 for free-of-charge, that will limit the use of the DEVA to energies 6MeV and above, while allowing the use of lower energies using the fixed field electron applicatiors.
Quantity in Commerce 168 total
Distribution Worldwide Distribution: USA, Canada, Belgium, Bulgaria, France, Germany, Hungary, India, Italy, Japan, Malaysia, P.R. China, Pakistan, Poland, Portugal, Qatar, Republic Korea, South Africa, Spain, Sweden, and United Kingdom.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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