Date Initiated by Firm | June 17, 2014 |
Date Posted | August 10, 2014 |
Recall Status1 |
Terminated 3 on December 15, 2014 |
Recall Number | Z-2180-2014 |
Recall Event ID |
68634 |
510(K)Number | K072485 |
Product Classification |
Accelerator, linear, medical - Product Code IYE
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Product | Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. |
Code Information |
Syngo RT Therapist (RTT 4.3.SP1) - model no. 08162815 Syngo RT Oncologist (RTO 4.3.SP1) - model no. 10568604 Syngo RT Therapist (RTT 4.3.SP1) for U.S. affected units only: 10010 10046 10586 No Syngo RT Oncologist (RTO 4.3.SP1) listed for U.S. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355
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For Additional Information Contact | Customer Support 610-219-6300 |
Manufacturer Reason for Recall | Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncologist 4.3SP1 software applications running on Siemens brand LINAC systems that may experience sporadic system crashes that will cause the inability to unload patient data. |
FDA Determined Cause 2 | Software design |
Action | In June, 2014, an urgent medical device correction field safety notice of improvement was sent to end users informing them of the product, problem, and action to be taken to avoid the potential safety issue. |
Quantity in Commerce | 56 |
Distribution | UT, WI, NY |
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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