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U.S. Department of Health and Human Services

Class 2 Device Recall Skytron

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  Class 2 Device Recall Skytron see related information
Date Initiated by Firm August 04, 2005
Date Posted September 13, 2006
Recall Status1 Terminated 3 on May 01, 2008
Recall Number Z-1497-06
Recall Event ID 35875
510(K)Number K950192  
Product Classification Surgical Table - Product Code FQO
Product Skytron General Purpose Surgical Table, battery model; Model 6600B, Dist. by Skytron, Grand Rapids, MI.
Code Information All units. Serial numbers 6600B-2D-002 through 6600B-2L-060.
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.
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