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U.S. Department of Health and Human Services

Class 2 Device Recall Jazzy Select 6 with XLR Port Harness

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  Class 2 Device Recall Jazzy Select 6 with XLR Port Harness see related information
Date Initiated by Firm February 01, 2010
Date Posted September 29, 2010
Recall Status1 Terminated 3 on November 20, 2014
Recall Number Z-2619-2010
Recall Event ID 54617
510(K)Number K042612  
Product Classification Wheelchair, Powered - Product Code ITI
Product Jazzy Select 6 with XLR Port Harness
Code Information all serial numbers
Recalling Firm/
Pride Mobility Products Corp
182 Susquehanna Ave
Exeter PA 18643
For Additional Information Contact Customer Support
Manufacturer 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 Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ITI and Original Applicant = PRIDE MOBILITY PRODUCTS CORP.