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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 Plussee related information
Date Initiated by FirmFebruary 14, 2018
Create DateApril 17, 2018
Recall Status1 Terminated 3 on May 16, 2019
Recall NumberZ-1401-2018
Recall Event ID 79766
510(K)NumberK121295 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Code Information Serial no: 3855 4019 4067 3953 5148 3793 5098 5222 3801 5388 3948 3755 5033 4015 5095 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactMs. Marlynne Galloway
610-448-6471
Manufacturer Reason
for Recall		Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
FDA Determined
Cause 2		Software design
ActionOn February 16, 2018, the recalling firm issued a Customer Advisory Notice via USPS Certified Mail to inform customers about the update of the Control Console software version 9.2.400 of the Digital Linear Accelerator to version 9.2.502. Customers were informed of the issues that would be fixed through this software update. Consignees were asked to instruct affected personnel accordingly, place the safety advisory notice in the device's instructions for use, and have personnel maintain awareness until the fix is implemented.
Quantity in Commerce15
DistributionWorldwide Distribution- US Nationwide in the states: AL, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NJ, NY, OH, OK, PA, RI, SC, TN, TX, WI, WV, and WY; and PR. International distribution to Nassau.
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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