FDA Medical Device Recalls (openFDA)
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 number
- Z-0186-05
- 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.
- Status
- Terminated
- Initiated
- 2004-09-15
- Posted
- 2004-11-06
- Terminated
- 2005-02-15
- Reason
- The firm established no medical device quality system, no established quality plan and no established quality procedures.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K880773"]
- PMA numbers
- not on file
- Product code
- GWE
- Firm FEI
- 3004174467
- Firm city
- Metuchen
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28