Events

Recall of Device Recall Milford Smartbase

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

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
    79627
  • Event Risk Class
    Class 2
  • Event Number
    Z-1420-2018
  • Event Initiated Date
    2018-03-07
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162854
  • 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
    Lift, patient, non-ac-powered - Product Code FSA
  • Reason
    Recalling firm was informed that as a result of combination of a weak spring and incorrect alignment of the locking pin for latching the leg positions, product legs folded inwards while lifting a person off a bed and the individual was dropped.
  • Action
    Autochair will issue a Retrofit Failsafe Kit. In the meantime, please quarantine current stock of SmartBase products until the failsafe device has been fitted and tested.

Device

Device Recall Milford Smartbase
  • Model / Serial
    All Lots
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    PA, and worldwide
  • Product Description
    Product: Milford Smartbase || Model # 9934105 Pride SmartBase || Pride product codes: LSMPLCG A & LSMPLCG B
  • Manufacturer
    Autochair

Manufacturer

Autochair
  • Manufacturer Address
    Autochair, Wood St North, Meadow Lane Industrial Estate, Alfreton United Kingdom
  • Manufacturer Parent Company (2017)
    Abc Mobility Holdings Ltd
  • Source
    USFDA