Device recall
Z-0635-2018: OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11…
FDA device recall · Class II · Oculus Optikgeraete GMBH
Key facts
| Recall number (Z-number) | Z-0635-2018 |
|---|---|
| Recall event | 78606 |
| Product | OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber, and… |
| Product code | MXK |
| Recalling firm | Oculus Optikgeraete GMBH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 22, 2018 |
| 510(k) numbers | K152311 |
| FEI number | 3002807782 |
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