Tidal Wave Carbon Dioxide Monitor, Model 610

• 4 recalls, same reason

  • Terminated Z-1294-2010 FDA Unclassified (pre-2012) ·initiated 19 Nov 2009
  • Terminated Z-1289-2010 FDA Unclassified (pre-2012) ·initiated 19 Nov 2009
  • Terminated Z-1283-2010 FDA Unclassified (pre-2012) ·initiated 19 Nov 2009
  • Terminated Z-1273-2010 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

K963327 ↗

FDA Product Code

CCK

Device Class

Class II

Regulation

21 CFR Part 868.1400

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Novametrix Model 510

  Class II

  FDA 510(k) K924626 Active Cleared 3 Dec 1993

• Novametrix Tcomette #809 Trans. Monitor

  Class II

  FDA 510(k) K800988 Active Cleared 28 May 1980

• TC02 M Oxygen Electrode Contact

  Class II

  FDA 510(k) K792009 Active Cleared 26 Oct 1979

• Model 1010 Physiological Signal Telemetry Monitor

  Class II

  FDA 510(k) K873672 Active Cleared 3 Dec 1987

• TC02M Electrode Adhesive Rings

  Class II

  FDA 510(k) K792010 Active Cleared 26 Oct 1979

• Novatracer Recorder

  Class I

  FDA 510(k) K811453 Active Cleared 10 Jul 1981

See all devices from Novametrix Medical Systems, Inc. →