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Terminated

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.

FDA Recall Z-2196-2008 · Posted 2008-06-28

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeKPQ
Date Initiated2008-03-10
Date Terminated2010-12-22
Product Quantity300 units

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

Worldwide and Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953233SIMVIEW 3000 CT OPTIONSiemens Medical Solutions USA, Inc. · 1996-11-29K946053SIMVIEW(TM) 3000Siemens Medical Solutions USA, Inc. · 1995-03-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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