Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0651-2009

High-low:x frame for the x:panda mechanical chair

R82 Inc. / initiated 2008-11-06 / Terminated / root cause: manufacturing process

Snug Seat Inc began a recall of High-low:x frame for the x:panda mechanical chair on . The reason FDA records is "Breakage in the welds was discovered in a section of the chair frame". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0651-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
R82 Inc.
Product
High-low:x frame for the x:panda mechanical chair.
Product code
IMS Support, Head And Trunk, Wheelchair
Reason for recall
Breakage in the welds was discovered in a section of the chair frame.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
Consignees were notified by letter dated 11/6/2008. Snug Seat sent a repair kit to their retail dealers on 11/18/2008. The kit includes a safety plate, written and video replacement instructions as well as the tools (allen wrench, crescent wrench and two nuts) necessary to make the safety update. Customers were identified using purchase order numbers, and product serial numbers to enable the dealers to identify the purchaser of the product. Due to HIPPA regulations, purchaser information was not available to Snug Seat, Inc. to contact directly. Written notification will be followed up with a telephone call to each dealer to ensure they have received the retrofit kit. Snug Seat will also insure they understand the importance of the kit and how to properly install and document receipt of the update for their customers.
Quantity in commerce
67 units
Distribution
Nationwide.
Product codes and lots
Article numbers 8911605-02, 8911605-02E, 8911606-02, 8911615-02, 8911615-02E and 8911616-02. Manufactured between 8/24/2007 and 10/3/2008.