Class 2 Device Recall Skytron

• Date Initiated by Firm: August 04, 2005
• Date Posted: September 13, 2006
• Recall Status: Terminated on May 01, 2008
• Recall Number: Z-1496-06
• Recall Event ID: 35875
• 510(K)Number: K950192
• Product Classification: Surgical Table - Product Code FQO
• Product: Skytron General Purpose Surgical Table; Model 6600, Dist. by Skytron, Grand Rapids, MI.
• Code Information: All units. Serial numbers 6600-2D-001 through 6600-2L-102.
• Recalling Firm/ Manufacturer: Skytron, Div. The KMW Group, Inc; 5000 36th St Se; Grand Rapids MI 49512-2008
• For Additional Information Contact: Larry Perez; 616-957-0500
• Manufacturer Reason for Recall: The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop.
• FDA Determined Cause: Other
• Action: A service bulletin was issued to distributors on 8/12/05 instructing them to identify customers and to retrofit these tables.
• Quantity in Commerce: 160 total
• Distribution: Nationwide.
• 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 = FQO