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U.S. Department of Health and Human Services

Class 2 Device Recall AMATECH

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  Class 2 Device Recall AMATECH see related information
Date Initiated by Firm July 12, 2004
Date Posted August 07, 2004
Recall Status1 Terminated 3 on May 05, 2005
Recall Number Z-1327-04
Recall Event ID 29589
Product Classification Table, Operating-Room, Ac-Powered - Product Code FQO
Product Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis Surgical Table
Catalog No: MDTNA2
Code Information 131613, 131614, 131615, 131616,152144, 152145, 152147, 152148 219039, 219040, 219042, 219043, 232800, 232801, 232802, 232803, 232804, 205395, 205396, 235327, 235329, 235330, 237473, 237465, 237467, 237468, 237469, 237470, 237471
Recalling Firm/
Manufacturer		 Allen Medical Systems
One Post Office Square
Acton MA 01720-3934
For Additional Information Contact Nancy Royalty
877-458-4884
Manufacturer Reason
for Recall		 Neuro adapter may fail to engage and adequately clamp to the surgical table, resulting in movement
FDA Determined
Cause 2		 Other
Action Allen Medical notified the two distributors by telephone on 7/12/04 and 7/16/04. A customer notifcation letter issued requesting return of the device for correction.
Quantity in Commerce 29 units
Distribution SC
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.
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