Diopsys Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Diopsys Inc
Lot Codes / Batch Numbers
10003, 10004, 10005, 10006, 10007, 10008, 10009, 100010, 100011, 100012, 100013, 100014, 100015, 100016.
Products Sold
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.
Diopsys Inc is recalling The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device, Manufac due to The firm established no medical device quality system, no established quality plan and no established quality procedures.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The firm established no medical device quality system, no established quality plan and no established quality procedures.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CT, IN, NJ, NY, OR
Page updated: Jan 10, 2026