Recall Z-2196-2008
Siemens Medical Solutions USA, Inc · initiated March 10, 2008
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.
Codes / lots: All codes.
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.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-2196-2008
- Initiated
- March 10, 2008
- Posted by FDA
- June 28, 2008
- Terminated
- December 22, 2010
- Product code
- KPQ – System, Simulation, Radiation Therapy
- Quantity
- 300 units
- Distribution
- Worldwide and Nationwide
- Recalling firm
- Siemens Medical Solutions USA, Inc, Concord, CA