Events

Recall of ECATS 2000 Safety Net Enclosure Medical Bed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Extended Care Air Therapy Systems 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
    36125
  • Event Risk Class
    Class 2
  • Event Number
    Z-0026-2007
  • Event Initiated Date
    2006-04-05
  • Event Date Posted
    2006-10-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48047
  • 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 - Product Code FNL
  • Reason
    Component defect- following assembly and distribution, two (2) bolts may bend in the bed frame, which may allow the bed to tip into the wall.
  • Action
    The firm sent a Product Advisory Letter to their distributor/customers on 4/5/2006. The letter instructs the distributors as to the correct way to handle the beds during movement, loading, and unloading onto delivery trucks. The letter also urges the distributors to inspect the bed frame units in inventory at their locations for the presence of any bending, or damage to the four frame bolts. The letter states that the company will replace the bolts as soon as possible when ever necessary.

Device

ECATS 2000 Safety Net Enclosure Medical Bed
  • Model / Serial
    Serial Numbers: E9084 - E9094 & E10001 - E10099. The serial # is found at the bottom of the stick on label. The label is affixed to the foot of the bed frame on the right hand side.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled medical beds were distributed to six (6) wholesale/distributor customers located in the following states: KS, TN, MI, PA, and LA.
  • Product Description
    ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
  • Manufacturer
    Extended Care Air Therapy Systems Inc

Manufacturer

Extended Care Air Therapy Systems Inc
  • Manufacturer Address
    Extended Care Air Therapy Systems Inc, 7165 Payne Rd, Roseville OH 43777-9711
  • Source
    USFDA