Recalls / —
—#149416
Product
PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
- FDA product code
- IYE — Accelerator, Linear, Medical
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K993425
- Affected lot / code info
- 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
Why it was recalled
Software patch installation to address several safety issues.
Root cause (FDA determination)
Software design
Action the firm took
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.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418
Distribution
- Distribution pattern
- Nationwide distribution
Timeline
- Recall initiated
- 2016-07-26
- Terminated
- 2018-05-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #149416. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.