Class 2 Device Recall Analogic

• Date Initiated by Firm: September 13, 2005
• Date Posted: October 12, 2005
• Recall Status: Terminated on August 07, 2006
• Recall Number: Z-0035-06
• Recall Event ID: 33337
• Product Classification: System, Monitoring, Perinatal - Product Code HGM
• Product: FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
• Code Information: System Serial Numbers: FA002021 FA002022 FA002025 FA002027 FA002033 FA002020 FA002029 FA002005 FA002041 FA002044 FA002046 FA002112 FA002097 FA002117 FA002028 FA002047 FA002048 FA002118 FA002034 FA002093 FA002095 FA002116 FA002008 FA002023 FA002030 FA002031 FA002009 FA002098 FA002040 FA002092 FA002024 FA002114 FA002113 FA002115 FA002026 FA002032 FA001328
• Recalling Firm/ Manufacturer: Analogic Corporation; Centennial Industrial park; 8 Centennial Drive; Peabody MA 01960-7902
• For Additional Information Contact: Dean Smith; 978-326-43333
• Manufacturer Reason for Recall: Unit may not power up due to faulty circuit board
• FDA Determined Cause: Other
• Action: Analogic notified customers by letter dated 9/13/05. Distributors were requested to notify their accounts and return units for replacement of the main circuit board.
• Quantity in Commerce: 37 units
• Distribution: CT, PR Foreign: Algeria, Chile,Ecudor, Mexico, South Africa, Vietnam, Russia, United Arab Emirates, Phillipines, Singapore, Korea, Malyasia
• 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.