Company:Oculus Optikgeraete GMBH
Date of Enforcement Report 2/28/2018
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
Recall Number Z-0635-2018
The device software versions have an anomaly which may produce an erroneous marking for the quality specification value
Oculus Optikgeraete GMBH, Wetzler, Germany on 11/21/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
US Distribution to the states of : CA and FL. There were no foreign/military/government accounts.