Class 3 Device Recall Enfant Pediatric VEP Vision Testing System

• Date Initiated by Firm: April 02, 2007
• Date Posted: April 26, 2010
• Recall Status: Terminated on April 27, 2010
• Recall Number: Z-1437-2010
• Recall Event ID: 55252
• 510(K)Number: K043491
• Product Classification: Vision Testing System - Product Code GWE
• Product: Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF.
• Code Information: Product number: 8510-0001-00 Rev 1; all units
• FEI Number: 3004174467
• Recalling Firm/ Manufacturer: Diopsys, Inc.; 16 Chapin Rd; Suite 911; Pine Brook NJ 07058
• For Additional Information Contact: Joseph Fontanetta; 973-244-0622
• Manufacturer Reason for Recall: The computer based system may lose test counts when the time in the device was changed during a changeover from standard time to daylight savings time in March 2007.
• FDA Determined Cause: Software design
• Action: Field Service personnel were sent an e-mail notification on 4/2/2007 which included a TZedit file to be downloaded. E-mails instructed reps to install the patch on their customers devices immediately. Field correction was completed 7/31/2007.
• Quantity in Commerce: 175 units
• Distribution: Nationwide distribution.
• 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 = GWE