FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: 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.
- Recall number
- Z-0235-2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- Status
- Terminated
- Initiated
- 2014-10-10
- Posted
- 2014-11-20
- Terminated
- 2017-06-29
- Reason
- 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
- Device Design
- Action
- 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.
- Quantity
- 6
- Distribution
- 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.
- Lot, serial or model codes
- Model numbers: 5496992, 5497016 with Serial numbers: 6035, 6080, 6029, 6032, 6019, 6001
- 510(k) numbers
- ["K953233"]
- PMA numbers
- not on file
- Product code
- KPQ
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28