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U.S. Department of Health and Human Services

Class 2 Device Recall ONCOR" Expression, Impression and Impression plus

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 Class 2 Device Recall ONCOR" Expression, Impression and Impression plussee related information
Date Initiated by FirmFebruary 14, 2017
Create DateMarch 20, 2017
Recall Status1 Terminated 3 on December 18, 2017
Recall NumberZ-1491-2017
Recall Event ID 76712
510(K)NumberK060226 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductONCOR" Expression ONCOR" Impression ONCOR" Impression plus
Code Information Device Model# 7360717, 5857920, 5857912
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactMarlynne Galloway
610-448-6478
Manufacturer Reason
for Recall		Software update
FDA Determined
Cause 2		Software design
ActionSiemens mailed an Customer Information Letter on 02/15/2017 to affected customers to inform them of a software update they plan to implement to reduce risk of collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table, using the SIMTEC-Auto Field Sequence Option.
Quantity in Commerce80 systems
DistributionDistributed throughout the United States
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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