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.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
