Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiatio
FDA device recall Z-0235-2015 · posted 2014-11-20 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPQ
- Quantity affected
- 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, Gree
- Date initiated
- 2014-10-10
- Date posted
- 2014-11-20
- Date terminated
- 2017-06-29
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIMVIEW 3000 CT OPTION (K953233) | Siemens Medical Solutions USA, Inc. | 1996-11-29 |