Recall Z-1437-2010 ยท GWE Stimulator, Photic, Evoked Response
Diopsys, Inc.
Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF.
| Date | Apr 26, 2010 (initiated Apr 2, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 175 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043491 | ENFANTTM Diopsys, Inc., Mar 16, 2005 |