FDA Device recall Z-2876-2016

ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver…

FDA Device
Class II
terminated
Published 2016-10-05

On 2016-10-05 the FDA classified a Class II recall of ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver… by Siemens Medical Solutions Usa, citing software patch installation to address several safety issues.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2876-2016
Classification	Class II
Status	terminated
Initiated	2016-07-26
Published	2016-10-05
Last updated	2026-09-13 11:54 UTC
Company	Siemens Medical Solutions Usa
Distribution	US

Product

ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.

Reason

Software patch installation to address several safety issues.

Identifiers

code_info	Model # 08162815, 8168754 Serial # 10019, 10626, 10651,10672.10678,10702,10703,10706,10712,10758,10767,10804,10625,100… 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

code_info

Model # 08162815, 8168754 Serial # 10019, 10626, 10651,10672.10678,10702,10703,10706,10712,10758,10767,10804,10625,100…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2876-2016%22

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