Device recall
Z-2437-2019: SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic…
FDA device recall · Class II · Heidelberg Engineering GmbH
Key facts
| Recall number (Z-number) | Z-2437-2019 |
|---|---|
| Recall event | 83568 |
| Product | SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device. |
| Product code | OBO |
| Recalling firm | Heidelberg Engineering GmbH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 2, 2020 |
| 510(k) numbers | K181594 |
| FEI number | 3002807157 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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