Events

Recall of Device Recall Fukuda Denshi patient monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fukuda Denshi USA, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72953
  • Event Risk Class
    Class 2
  • Event Number
    Z-0661-2016
  • Event Initiated Date
    2015-12-21
  • Event Date Posted
    2016-01-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142581
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    A possible malfunction where a short-term battery error message has appeared and has been traced back to a bad (damaged) lithium-ion capacitor (short-term backup battery).
  • Action
    Fukuda Denshi USA, Inc. of Redmond, WA plans to perform 100% field correction of units distributed in the US. The Recall/Field Correction Notice letter (FCN-A01-201512), dated December 21, 2015, and the Customer Confirmation Sheet will be sent to consignees using a clearly red-marked URGENT via Express Mail. The consignees are requested to fill out the Customer Confirmation Sheet and return via fax to 888-224-7090, email to DBlakely@fukuda.com, or send via postal service back to Fukuda Denshi USA, Inc. in a pre-stamped envelope. Consignee can call Doug Blakey directly at 210-240-4521 with any questions or concerns.

Device

Device Recall Fukuda Denshi patient monitor
  • Model / Serial
    50400001, 50400002, 50400003, 50400004, 50400011, 50400012, 50400018, 50400019, 50400020, 50400021, 50400022, 50400023, 50400024, 50400025, 50400026, 50400027, 50400028, 50400029, 50400030, 50400031, 50400032, 50400033, 50400034, 50400035, 50400036, 50400037, 50400038, 50400039, 50400040, 50400042, 50400043, 50400044, 50400045, 50400046, 50400047, 50400048, 50400049, 50400050, 50400051, 50400052, 50400053, 50400054, 50400055, 50400056, 50400057, 50400058, 50400059, 50400060, 50400061, 50400062, 50400063, 50400064, 50400065, 50400066, 50400067, 50400068, 50400069, 50400070, 50400071, 50400072, 50400073, 50400074, 50400075, 50400076, 50400077, 50400078, 50400084, 50400093, 50400094, 50400095, 50400096, 50400097, 50400098, 50400099, 50400100, 50400101, 50400102, 50400103, 50400104, 50400105, 50400106, 50400107, 50400108, 50400109, 50400110, 50400111, 50400112, 50400113, 50400114, 50400115, 50400116, 50400117, 50400118, 50400119, and 50400120.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI.
  • Product Description
    Fukuda Denshi patient monitor model DS-8100M and DS-8100N. || The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is || meant to acquire and monitor physiological signals from patients.
  • Manufacturer
    Fukuda Denshi USA, Inc.

Manufacturer

Fukuda Denshi USA, Inc.
  • Manufacturer Address
    Fukuda Denshi USA, Inc., 17725 NE 65th St Ste C, Redmond WA 98052-4911
  • Manufacturer Parent Company (2017)
    Fukuda Denshi Co., Ltd.
  • Source
    USFDA