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
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Product | Jazzy Select 6 with XLR Port Harness |
Code Information |
all serial numbers |
Recalling Firm/ Manufacturer |
Pride Mobility Products Corp 182 Susquehanna Ave Exeter PA 18643
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For Additional Information Contact | Customer Support 866-222-6212 |
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 | 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 |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = ITI
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