Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2619-2010

Jazzy Select 6 with XLR Port Harness

Pride Mobility Products Corp / initiated 2010-02-01 / Terminated

Pride Mobility Products Corp began a recall of Jazzy Select 6 with XLR Port Harness on . The reason FDA records is "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-2619-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Pride Mobility Products Corp
Product
Jazzy Select 6 with XLR Port Harness
Product code
ITI Wheelchair, Powered
Reason for recall
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.
FDA root cause
Other
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.
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 codes and lots
all serial numbers