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.
데이터 추가 비고
Wheelchair, powered - Product Code ITI
원인
There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base.
조치
The firm initiated the recall by letter on 09/01/2017. The distributor/dealers were instructed as follows:
LOG INTO CORRECTION WEB PORTAL
Immediately log into www.permobilfsa.com. Log in with the following ID and Password.
CEASE DISTRIBUTION OF EXISTING INVENTORY
Please examine your inventory for the serial numbers assigned to you, cease distribution, and quarantine those chairs.
IMMEDIATELY PERFORM INSPECTION
If you have distributed these serial numbers to end users, you must immediately contact them to perform a visual inspection of the top plate assembly looking for obvious signs of cracking.
If the top plate shows no signs of cracking the wheelchair may continue to be used in accordance with the owners manual until the correction is performed.
If the top plate does show signs of cracking please inform the user that the chair cannot be used until the correction is performed. Next, log into the web portal to obtain further instructions and assistance. In these cases which are expected to be rare, we will assist with a temporary solution to keep the client mobile during the time between inspection and correction.
PERFORMING THE CORRECTION
You will be notified when repair kits are available and the process to follow to obtain the proper kit for the serial number you are correcting.
The web portal will include a template letter to send to end users explaining the hazard and the need to cooperate with this correction effort. Correction instructions and related supporting materials will also be available. We are also providing the end user with a certificate for a free light kit towards the purchase of a new Permobil power chair.
Please contact your Permobil sales representative if you have any questions regarding this correction.
Nationwide and Australia, Benelux, Canada, Denmark, Finland, France, Germany, Israel, Norway, Sweden, and UAE
제품 설명
Electric Wheelchairs: || a) C300 CORPUS II || b) C350 CORPUS II || c) C400 CORPUS II || d) C400 CORPUS II LR || e) C500 CORPUS II || f) C500 CORPUS II LR