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U.S. Department of Health and Human Services

Class 3 Device Recall Enfant Pediatric VEP Vision Testing System

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  Class 3 Device Recall Enfant Pediatric VEP Vision Testing System see related information
Date Initiated by Firm April 02, 2007
Date Posted April 26, 2010
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = DIOPSYS INC.
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