Z-1488-2017Class II

ARTISTE" MV System

Name: Z-1488-2017 ARTISTE" MV System
Creator: Siemens Medical Solutions USA, Inc
Published: 2017-02-14
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-02-14 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTISTE" MV System on 2017-02-14. FDA classified it as Class II and gives the reason as "Software update". 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-1488-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-14
Posted: 2017-03-20
Terminated: 2017-12-18
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTISTE" MV System
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Software update
Root cause tag: software
FDA root cause: Software design
Action: Siemens mailed an Customer Information Letter on 02/15/2017 to affected customers to inform them of a software update they plan to implement to reduce risk of collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table, using the SIMTEC-Auto Field Sequence Option.
Quantity in commerce: 80 systems
Distribution: Distributed throughout the United States
Product codes and lots: Device Model# 8139789

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1488-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1488-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20
Z-1489-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20
Z-1490-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20
Z-1491-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20

Product code IYE

K072485Class IIArtiste Mv SaSiemens Medical Solutions USA, Inc. / cleared 2007-12-27

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)