Advanced Turbo Drive System

• 2 recalls, same reason

  • Terminated Z-0917-2013 FDA Class III ·initiated 24 Jan 2013
  • Terminated Z-0916-2013 FDA Class III ·initiated 24 Jan 2013

  The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance.

510(k) Number

K050519 ↗

FDA Product Code

GEY

Device Class

Class I

Regulation

21 CFR Part 878.4820

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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