Events

Recall of Device Recall Hoana LifeBed

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

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
    46154
  • Event Risk Class
    Class 2
  • Event Number
    Z-0592-2008
  • Event Initiated Date
    2007-11-07
  • Event Date Posted
    2008-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66889
  • 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
    Bed-Patient Monitor - Product Code KMI
  • Reason
    Bed exit failure: failure to recognize "bed exit" when the feature is active due to a software anomaly.
  • Action
    On 11/7/07, all consignees were notified via an untitled letter and on-site visit by the firm's sales representative, informing them of the affected product and providing instructions on the recall. The recalling firm will arrange for installation of a software fix at each consignee.

Device

Device Recall Hoana LifeBed
  • Model / Serial
    All Serial Numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide including states of HI, CA, TX and MA
  • Product Description
    Hoana LifeBed Patient Vigilance System, (Intelligent Medical Vigilance System),Model Number: 010135-01, Product distributed by Hoana Medical, Inc., 828 Fort St. Mall, Suite 620, || Honolulu, HI
  • Manufacturer
    Hoana Medical

Manufacturer

Hoana Medical
  • Manufacturer Address
    Hoana Medical, 828 Fort Street Mall Ste 620, Honolulu HI 96813-4314
  • Manufacturer Parent Company (2017)
    Hoana Medical Inc.
  • Source
    USFDA