The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device, Manufactured by Diopsys, Inc
FDA device recall Z-0186-05 · posted 2004-11-06 · Terminated
Recall details
- Recalling firm
- Diopsys Inc
- Reason for recall
- The firm established no medical device quality system, no established quality plan and no established quality procedures.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GWE
- Quantity affected
- 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 ac
- Date initiated
- 2004-09-15
- Date posted
- 2004-11-06
- Date terminated
- 2005-02-15
- Location
- Metuchen, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE VENUS SYSTEM (K880773) | Neuroscientific Corp. | 1988-08-18 |