Device recall
Z-0186-05: The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision…
FDA device recall · Class III · Diopsys Inc
Key facts
| Recall number (Z-number) | Z-0186-05 |
|---|---|
| Recall event | 29999 |
| 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… |
| Product code | GWE |
| Recalling firm | Diopsys Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 15, 2005 |
| 510(k) numbers | K880773 |
| FEI number | 3004174467 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database