Events

Recall of Device Recall Jazzy Select 6 with XLR Port Harness

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

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
    54617
  • Event Risk Class
    Class 2
  • Event Number
    Z-2619-2010
  • Event Initiated Date
    2010-02-01
  • Event Date Posted
    2010-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88792
  • 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
    Wheelchair, Powered - Product Code ITI
  • Reason
    Improper set-up of the wire harness can allow wires to be pulled from their intended position and become caught under the motor mounting bracket located under the powered wheelchair. this can cause the wire connector and/or the wire itself to be pulled or pinched which can lead to a short or open circuit.
  • Action
    The recalling firm issued recall notifications with response cards to their dealers. Included with the notification was fasteners and an example letter for customer notification of the problem. Dealers were instructed to contact the end users to make arrangements with the customer/end user to verify that the devices were properly set up. If the dealers' inspection revealed that additional fasteners were required they dealer would install them. The recalling firm also issued a recall letter to consumers. The consumer recall letter included instructions that if the correction was completed by anyone other than the wheelchair provider, then the consumer should schedule an appointment with the wheelchair provider to ensure the correction was completed properly.

Device

Device Recall Jazzy Select 6 with XLR Port Harness
  • Model / Serial
    all serial numbers
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to dealers nationwide who further shipped the product to end users. The product was also shipped to distributors in Canada, Australia and United Kingdom
  • Product Description
    Jazzy Select 6 with XLR Port Harness
  • Manufacturer
    Pride Mobility Products Corp

Manufacturer

Pride Mobility Products Corp
  • Manufacturer Address
    Pride Mobility Products Corp, 182 Susquehanna Ave, Exeter PA 18643
  • Manufacturer Parent Company (2017)
    Pride Mobility Products Corp
  • Source
    USFDA