Events

Recall of Device Recall WellHome 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
    55507
  • Event Risk Class
    Class 2
  • Event Number
    Z-2166-2010
  • Event Initiated Date
    2009-02-02
  • Event Date Posted
    2010-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91006
  • 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
    Non-Invasive Blood Pressure Measurement System - Product Code DXN
  • Reason
    Touch panel may become unresponsive.
  • Action
    Zoe Medical notified the 2 distributors by e-mail on January 26, 2009 and Feb 6, 2009 of the recall, requesting return of the units for correction.

Device

Device Recall WellHome Monitor
  • Model / Serial
    Serial numbers WFD5373, WFD5374, WFD5375, WFD5376, WFD5377, WFD5378, WFD5379,WFD5380, WFD5381, WFD5382, WFD5383, WFD5384, WFD5385, WFD5386, WFD5387, WFD5388, WFD5389, WFD5390, WFD5392, WFD5393, WFD5394,WFD5395, WFD5396, WFD5398, WFD5399, WFD5400, WFD5401, WFD5402, WFD5403, WFD5404, WFD5405, WFD5406, WFD5407, WFD5408, WFD5409,WFD5410, WFD5411, WFD5412, WFD5413, WFD5414, WFD5415, WFD5416, WFD5417, WFD5418, WFD5419, WFD5420, WFD5421, WFD5422, WFD5423,\/VFD5424, VVFD5425, WFD5426, WFD5427, WFD5428, WFD5429, WFD5431, WFD5432, WFD5435, WFD5436, WFD5437, WFD5438, and WFD5439.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- MA and MD.
  • Product Description
    The Well@Home Monitor by Patient Care technologies || Model 179-2150 || Intended to be used as a clinical tool for remotely monitoring a patient's health status at home or in another healthcare facility on a spot check basis.
  • 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