Z-2196-2008

Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and MEV ASIM S systems...

Name: Z-2196-2008 Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and MEV ASIM S systems...
Creator: Siemens Medical Solutions USA, Inc
Published: 2008-03-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-03-10 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and MEV ASIM S systems; Part Number: 5488460; Product is manufactured and... on 2008-03-10. The reason FDA records is "The firm sent an Update Instruction, "TH003/08/S" for Motion Enable Switch/holder assembly. The switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion...". 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-2196-2008
Status: Terminated
Initiated: 2008-03-10
Posted: 2008-06-28
Terminated: 2010-12-22
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and MEV ASIM S systems; Part Number: 5488460; Product is manufactured and distributed by Siemens Medical Solutions, Oncology Care System, 4040 Nelson Ave, Concord CA The product is indicated for use in Radiation therapy simulation.
Product code: KPQ System, Simulation, Radiation Therapy
Reason for recall: The firm sent an Update Instruction, "TH003/08/S" for Motion Enable Switch/holder assembly. The switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion and serious injury may result.
Root cause tag: software
FDA root cause: Software design
Action: On June 25, 2008 all consignees were notified via written letter and on-site visit by the firm's sales representative, informing them that the switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion and serious injury may result and providing instructions on the recall. A new software version will be provided. For assistance contact Siemens at 1-925-246-8407.
Quantity in commerce: 300 units
Distribution: Worldwide and Nationwide
Product codes and lots: All codes.

Product code KPQ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)