Date Initiated by Firm |
August 04, 2005 |
Date Posted |
September 13, 2006 |
Recall Status1 |
Terminated 3 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 2 |
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 and Original Applicant = SKYTRON, DIV. THE KMW GROUP, INC.
|