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Terminated

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

FDA Recall Z-1437-2010 · Posted 2010-04-26

Recalling FirmDiopsys, Inc.
Recall StatusTerminated
Product CodeGWE
Date Initiated2007-04-02
Date Terminated2010-04-27
Product Quantity175 units

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043491ENFANTTMDiopsys, Inc. · 2005-03-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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