Recalls / —
—#131032
Product
Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer.
- FDA product code
- KPQ — System, Simulation, Radiation Therapy
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K953233
- Affected lot / code info
- Model numbers: 5496992, 5497016 with Serial numbers: 6035, 6080, 6029, 6032, 6019, 6001
Why it was recalled
Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simulation system components could not be stopped with usual hand control commands or by use of the collision detection functionality. It is possible that simulation system components could collide with patient and/or system equipment.
Root cause (FDA determination)
Device Design
Action the firm took
Customers were initially notified about the issue by letter on January 7, 2014 (this action was reported as Z-0786-2014 which has been terminated). Siemens promised to notify them when a fix became available. Customer letter, dated November 7, 2014, was sent to notify end users that a fix has become available and Siemens would contact them to schedule an appointment for the correction.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355
Distribution
- Distribution pattern
- Worldwide Distribution - US Nationwide in the states of PA, KY, LA, MA, MI, and CA; and countries of: Argentina, Belarus, Bulgaria, Costa Rico, P.R. China, Curacao, Egypt, Repulic Korea, Germany, Greece, Hungary, Italy, Iraq, Jordan, Malaysia, Palestanian Ter, Poland, Thailand, Turkey, and Vietnam.
Timeline
- Recall initiated
- 2014-10-10
- Posted by FDA
- 2014-11-20
- Terminated
- 2017-06-29
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #131032. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.