Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C5

FDA device recall Z-0005-2018 · posted 2017-10-03 · Terminated

Recall details

Recalling firm

Permobil, Ab

Reason for recall

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

ITI

Quantity affected

5539 units

Distribution

Nationwide and Australia, Benelux, Canada, Denmark, Finland, France, Germany, Israel, Norway, Sweden, and UAE

Date initiated

2017-09-01

Date posted

2017-10-03

Date terminated

2021-05-04

Location

Timra, Sweden

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