Bci 3180 Pulse Oximeter

• • Terminated Z-0919-2010 FDA Unclassified (pre-2012) ·initiated 15 Jan 2010

  Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or Veterinary), 8400 Capnocheck II Capnometer(Human or Veterinary) and V6400 Invasive Pressure Monitor (Veterinary). The affected Electri-Cord AC power cords are eq

• • Terminated Z-1619-2008 FDA Unclassified (pre-2012) ·initiated 27 Feb 2008

  The Smith Medical PM, Inc. BCI 3180 Pulse Oximeter tantalum capacitors C38, C72, C74, and C98 were installed backwards during assembly at the board manufacturer. This exposes the components to reverse polarity voltages that may lead to their pre-mature failure. As a result, the identified monitors may exhibit failure modes such as the monitor may shut down and not produce alarms or signals to

510(k) Number

K020350 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Bci 3178 Pediatric Pulse Oximetry Sensor

  Class II

  FDA 510(k) K020739 Active Cleared 3 Jun 2002

• Irrigator, Body Cavity

  Class II

  FDA 510(k) K781918 Active Cleared 15 Feb 1979

• Bci 6004 Nibp Monitor with Nellcor Pulse Oximeter

  Class II

  FDA 510(k) K031742 Active Cleared 18 Aug 2003

• 3420 Digit Pulse Oximeter, Model 3420

  Class II

  FDA 510(k) K013171 Active Cleared 3 Jan 2002

• Capnocheck Open recall

  Class II

  FDA 510(k) K941982 Active Cleared 17 Oct 1994

• Sharps Container 18 Gallon

  Class II

  FDA 510(k) K944121 Active Cleared 27 Jan 1995

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