Diopsys, Inc. Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF.
Brand
Diopsys, Inc.
Lot Codes / Batch Numbers
Product number: 8510-0001-00 Rev 1, all units
Products Sold
Product number: 8510-0001-00 Rev 1; all units
Diopsys, Inc. is recalling Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Cl due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026