Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF.
FDA device recall Z-1437-2010 · posted 2010-04-26 · Terminated
Recall details
- Recalling firm
- Diopsys, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GWE
- Quantity affected
- 175 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2007-04-02
- Date posted
- 2010-04-26
- Date terminated
- 2010-04-27
- Location
- Pine Brook, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENFANTTM (K043491) | Diopsys, Inc. | 2005-03-16 |