Device recall
Z-1535-2018: Widefield OCT software feature for the Spectralis HRA+OCT and variants
FDA device recall · Class II · Heidelberg Engineering
Key facts
| Recall number (Z-number) | Z-1535-2018 |
|---|---|
| Recall event | 79453 |
| Product | Widefield OCT software feature for the Spectralis HRA+OCT and variants |
| Product code | OBO |
| Recalling firm | Heidelberg Engineering |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 4, 2020 |
| FEI number | 3000204964 |
At a glance
- None 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