Z-2876-2016Class II

ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear...

Name: Z-2876-2016 ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-07-26
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-07-26 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and... on 2016-07-26. FDA classified it as Class II and gives the reason as "Software patch installation to address several safety issues". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2876-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-26
Posted: 2016-09-23
Terminated: 2018-05-10
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Software patch installation to address several safety issues.
Root cause tag: software
FDA root 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2876-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2876-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-23
Z-2877-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-23
Z-2878-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-23

Product code IYE

K103606Class IIArtiste Solution with Sys_vb50 UpdateSiemens Medical Solutions USA, Inc. / cleared 2011-04-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)