Recall Z-2196-2008 ยท KPQ System, Simulation, Radiation Therapy
Siemens Medical Solutions USA, Inc
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.
| Date | Jun 28, 2008 (initiated Mar 10, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | 300 units |
| Distribution | Worldwide and Nationwide |
| FDA record | Open on fda.gov |