Z-1437-2010

Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type...

Name: Z-1437-2010 Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type...
Creator: Diopsys, Inc.
Published: 2007-04-02
License: https://open.fda.gov/license/

Diopsys Inc / initiated 2007-04-02 / Terminated / root cause: software

FDA source

Diopsys, Inc. began a recall of Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF on 2007-04-02. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1437-2010
Status: Terminated
Initiated: 2007-04-02
Posted: 2010-04-26
Terminated: 2010-04-27
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.
Product code: GWE Stimulator, Photic, Evoked Response
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.
Root cause tag: software
FDA 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 in commerce: 175 units
Distribution: Nationwide distribution.
Product codes and lots: Product number: 8510-0001-00 Rev 1; all units

Product code GWE

K043491Class IIEnfanttmDiopsys, Inc. / cleared 2005-03-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)