| Class 2 Device Recall PRIMUS HI |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = IYE
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