Class 2 Device Recall PRIMUS Accelerator, Linear, Medical

• Date Initiated by Firm: July 26, 2016
• Create Date: September 23, 2016
• Recall Status: Terminated on May 10, 2018
• Recall Number: Z-2877-2016
• Recall Event ID: 75113
• 510(K)Number: K993425
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
• Code Information: Model # 08162815, 8168754 Serial # 10019, 10626, 10651,10672.10678,10702,10703,10706,10712,10758,10767,10804,10625,10063,10770,10831,10008,10786,10789,10756,10045,10589,10698,10642,10792,10822,10821,10849,10850,10592,10676,10785,10047,10722,10665,10754,10004,10007,10823,10002,10803,10074,10778,10046,10762,10835,10694,10844,10603,10788,10600,10634,10570,10815,10744,10624,10513,10015,10805,10635,10755,10776,10022,10524,10586,10035,10843,10828,10578,10790,10817,10105,10699,10793,10794,10784,10783,10096,10501,10796,10024,10021,10023,10641,90245,10795,10571,10013,10039,10658,10005,10725,10025,10707,10708,10798,10010,10814,10050,10763,10580,10846,10791
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: Anastasia Sokolova; 610-219-4834
• Manufacturer Reason for Recall: Software patch installation to address several safety issues.
• FDA Determined Cause: Software design
• Action: Siemens sent a Field Safety Notice to all affected customers informing them of a new software patch that they plan to install to address software issues. Customers were advised to notify anyone at their organization who should be aware of the information contained in the Notice. Customers were also advised to include the Field Safety Notice in their System Owner Manual, chapter "Safety Advisory Letters" where it should remain. For questions regarding this recall call 610-219-4834.
• Quantity in Commerce: 103 accelerators
• Distribution: Nationwide distribution
• 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