FDA Device

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.

Hazard

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.

What You Should Do

Remedy

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.

Products

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
Brand
Siemens Medical Solutions USA, Inc
UPC
All codes.

Units Affected

300 units