Recall Z-0186-05 ยท GWE Stimulator, Photic, Evoked Response
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
| Date | Nov 6, 2004 (initiated Sep 15, 2004) |
| Status | Terminated |
| 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 ar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880773 | THE VENUS SYSTEM Neuroscientific Corp., Aug 18, 1988 |