Z-0186-05

The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device, Manufactured by...

Name: Z-0186-05 The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device, Manufactured by...
Creator: Diopsys Inc
Published: 2004-09-15
License: https://open.fda.gov/license/

Diopsys Inc / initiated 2004-09-15 / Terminated

FDA source

Diopsys Inc began a recall of The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device, Manufactured by Diopsys, Inc., 355 Main St., Metuchen, NJ 08840... on 2004-09-15. The reason FDA records is "The firm established no medical device quality system, no established quality plan and no established quality procedures". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0186-05
Status: Terminated
Initiated: 2004-09-15
Posted: 2004-11-06
Terminated: 2005-02-15
Recalling firm: Diopsys Inc
Product: 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.
Product code: GWE Stimulator, Photic, Evoked Response
Reason for recall: The firm established no medical device quality system, no established quality plan and no established quality procedures.
FDA root cause: Other
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.
Quantity in commerce: 18 units
Distribution: 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.
Product codes and lots: No manufacturing codes are affixed to the units. The firm maintains some in-house identification numbers which are: 10001; 10003; 10004; 10005; 10006; 10007; 10008; 10009; 100010; 100011; 100012; 100013; 100014; 100015; 100016.

Product code GWE

K880773Class IIThe Venus SystemNeuroscientific Corp. / cleared 1988-08-18

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)