Novametrix Model 7100 Comb. End Tidal CO2 & Pul Ox

• 3 recalls, same reason

  • Terminated Z-1287-2010 FDA Unclassified (pre-2012) ·initiated 19 Nov 2009
  • Terminated Z-1268-2010 FDA Unclassified (pre-2012) ·initiated 19 Nov 2009
  • Terminated Z-1269-2010 FDA Unclassified (pre-2012) ·initiated 19 Nov 2009

  Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may crack and fail at/or inside the plug. Potential for burns or electrical shock.

510(k) Number

K920379 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Novametrix Medical Systems, Inc. →