Device recall
Z-3215-2026: Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex…
FDA device recall · Class II · Heidelberg Engineering GmbH
Key facts
| Recall number (Z-number) | Z-3215-2026 |
|---|---|
| Recall event | 99595 |
| Product | Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segment of the eye |
| Product code | OBO |
| Recalling firm | Heidelberg Engineering GmbH |
| Recall class | Class II |
| Status | Open, Classified |
| 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