Recalls / —
—#71815
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.
- FDA product code
- KPQ — System, Simulation, Radiation Therapy
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K946053, K953233
- Affected lot / code info
- All codes.
Why it was recalled
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 (FDA determination)
Software design
Action the firm took
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.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 4040 Nelson Ave, Concord, California 94520-1200
Distribution
- Distribution pattern
- Worldwide and Nationwide
Timeline
- Recall initiated
- 2008-03-10
- Posted by FDA
- 2008-06-28
- Terminated
- 2010-12-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #71815. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.