Class 2 Device Recall AMATECH

• Date Initiated by Firm: July 12, 2004
• Date Posted: August 07, 2004
• Recall Status: Terminated 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: 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.