The Recall Desk
HighFDA (Devices)·Z-0235-2015·Announced 2014-11-26

Siemens SimView NT Simulation System Recalled for Movement Control Defect

Siemens is recalling six SimView NT simulation systems because a rare defect may prevent components from stopping, risking collision with patients or equipment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria for potential collision with patients or equipment.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling six units of the SimView NT and SimView NT with IDI simulation systems. These devices are used for radiation therapy simulation to plan cancer treatment. The recall involves specific model numbers 5496992 and 5497016 with serial numbers 6035, 6080, 6029, 6032, 6019, and 6001.

The recall was initiated because Siemens identified a very rare occurrence where an intended movement of the simulation system components could not be stopped using usual hand control commands or the collision detection functionality. This defect creates a possibility that the simulation system components could collide with a patient and/or system equipment.

The affected units were distributed worldwide, including in the United States (PA, KY, LA, MA, MI, and CA) and in various international locations. Users of these systems should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and necessary corrective actions.

The recalled product

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.
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Model numbers: 5496992
  • 5497016 with Serial numbers: 6035
  • 6080
  • 6029
  • 6032
  • 6019
  • 6001

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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