FDA Medical Device Recalls (openFDA)
Diopsys, Inc.: Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF.
- Recall number
- Z-1437-2010
- Recalling firm
- Diopsys, Inc.
- Product
- Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF.
- Status
- Terminated
- Initiated
- 2007-04-02
- Posted
- 2010-04-26
- Terminated
- 2010-04-27
- 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.
- Lot, serial or model codes
- Product number: 8510-0001-00 Rev 1; all units
- 510(k) numbers
- K043491
- PMA numbers
- not on file
- Product code
- GWE
- Firm FEI
- 3004174467
- Firm city
- Pine Brook
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28