Events

Recall of Device Recall Ultraview DM3 Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zoe Medical Incorporated.

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
    62939
  • Event Risk Class
    Class 2
  • Event Number
    Z-2380-2012
  • Event Initiated Date
    2012-06-06
  • Event Date Posted
    2012-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112079
  • 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
    Unit fails to power up, resulting in an equipment alarm.
  • Action
    The firm, Zoe Medical, coordinated with the Distributor via email on June 7, 2012. The email described the product, problem and actions to be taken. Zoe will remove product the site and return the units for correction. If you have any questions, contact Manager, Global Technical Support at 425-657-7200 ext 5508.

Device

Device Recall Ultraview DM3 Monitor
  • Model / Serial
    Serial Numbers: FFD3291, FFD3292, FFD3293, FFD3294, FFD3295, FFD3296, FFD3297, FFD3298, FFD3299, FFD3300, FFD3301, FFD3302, FFD3303, FFD3304, FFD3306, FFD3307, FFD3308, FFD3309, FFD3310, FFD3312, FFD3313, FFD3314, FFD3315, FFD3316,FFD3317, FFD3318, FFD3319, FFD3320, FFD3321, FFD3579, FFD3771, FFD3772, FFD3814, FFD3815, FFD3817
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: WA only.
  • Product Description
    Spacelabs Ultraview DM3 Monitor || Model Number: 91330-NT || The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.
  • Manufacturer
    Zoe Medical Incorporated

Manufacturer

Zoe Medical Incorporated
  • Manufacturer Address
    Zoe Medical Incorporated, 460 Boston St, Topsfield MA 01983-1223
  • Manufacturer Parent Company (2017)
    Zoe Medical Incorporated
  • Source
    USFDA