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
- Recall Number
- Z-0186-05
- Event Number
- 29999
- Firm
- Diopsys Inc
- FEI Number
- 3004174467
- Product Code
- GWE
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 15, 2004
- Posted
- November 6, 2004
- Terminated
- February 15, 2005
- Address
- 355 Main St, Metuchen, NJ, 08840
Description
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.
The firm established no medical device quality system, no established quality plan and no established quality procedures.
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.
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.
18 units