The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device, Manufactured by Diopsys, Inc., 355 Main St., Metuchen, NJ 08840. Each medical device unit is assembled and contains an 18 inch flat panel vision stimulator panel, a 17 inch flat panel operator monitor, a 2.25 inch thermal printer, a mobile point of care cart, medical grade battery back-up, speaker, a CPU with floppy and CD drives, a camera and an isolation transformer.
FDA Recall Z-0186-05 · Posted 2004-11-06
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Recalling FirmDiopsys Inc
Recall StatusTerminated
Product CodeGWE
Date Initiated2004-09-15
Date Terminated2005-02-15
Product Quantity18 units
Reason for Recall
The firm established no medical device quality system, no established quality plan and no established quality procedures.
Firm Action
The firm sent out a recall letter to their customers on 09/14/2004 stating that a field correction will be conducted at each site.
Root Cause
Other
Distribution Pattern
The firm distributes the Enfant VEP medical device systems in 3 states, NY, NJ, and CT at the current time. There is no international distribution at this time. There are no Government, or military accounts. The rental/leasing of the units are direct. No contracts have been established. There are 17 domestic consignees.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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