Model 520A Novametrix Pulse Oximeter

• 4 recalls, same reason

  • Terminated Z-1297-2010 FDA Unclassified (pre-2012) ·initiated 19 Nov 2009
  • Terminated Z-1295-2010 FDA Unclassified (pre-2012) ·initiated 19 Nov 2009
  • Terminated Z-1305-2010 FDA Unclassified (pre-2012) ·initiated 19 Nov 2009
  • Terminated Z-1296-2010 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.

• • Terminated Z-1559-2009 FDA Unclassified (pre-2012) ·initiated 13 May 2009

  Neonatal/Pediatric SPU Sensors may be incorrectly packaged in pouches labeled for Adult/Pediatric SPU Sensors.

510(k) Number

K913516 ↗

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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  Class II

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• 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

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