Primus recall: Software Issue
PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of…
Why was Primus recalled?
Software patch installation to address several safety issues.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 103 accelerators
- Distribution
- Nationwide distribution
- Recall date
- October 5, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)