Recall Z-0635-2018 ยท MXK Device, Analysis, Anterior Segment
Oculus Optikgeraete GMBH
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 lens of the eye, to evaluate corneal shape, analyze condition of the lens (opaque crystalline lens
| Date | Nov 21, 2017 |
| Status | Terminated |
| Reason | The device software versions have an anomaly which may produce an erroneous marking for the quality specification value |
| Root cause | Software design |
| Action | Oculus issued an email on November 21, 2017 to their U.S. subsidiary which contained a Mandatory Software Update notification. The email informed the U.S. subsidiary that a mandatory software update was planned for the Pentacam AXL in possession of their customers, provided the software versions affected, and the reason for the mandatory update. The email explained the USB thumb drive will be shipped to the U.S. subsidiary for each serial number that may be affected. The U.S. subsidiary was to match the serial numbers to their customers and complete the attached customer letter for issuance |
| Quantity | 83 devices |
| Distribution | US Distribution to the states of : CA and FL. There were no foreign/military/government accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152311 | Pentacam AXL Oculus Optikgerate GmbH, Jan 20, 2016 |