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U.S. Department of Health and Human Services

Class 2 Device Recall PRIMUS HI

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  Class 2 Device Recall PRIMUS HI see related information
Date Initiated by Firm February 14, 2018
Create Date April 17, 2018
Recall Status1 Terminated 3 on May 16, 2019
Recall Number Z-1402-2018
Recall Event ID 79766
510(K)Number K993425  
Product Classification Accelerator, linear, medical - Product Code IYE
Product PRIMUS HI, Digital Linear Accelerator, Model No. 04504200

Product Usage:
The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Code Information Serial no: 2958 3832 3241 3574 3519 3922 3924 3361 4036 3302 70-4185 3949 3547 3657 3622 3731 3565 5153 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Ms. 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
Action On 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 Commerce 18
Distribution Worldwide 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 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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