Model 70100, software Cl II OCULUS Pentacam AXL

Company:Oculus Optikgeraete GMBH
Date of Enforcement Report 2/28/2018
Class lI:

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
Recall Number Z-0635-2018

REASON
The device software versions have an anomaly which may produce an erroneous marking for the quality specification value

RECALLING FIRM/MANUFACTURER
Oculus Optikgeraete GMBH, Wetzler, Germany on 11/21/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
83 devices

DISTRIBUTION
US Distribution to the states of : CA and FL. There were no foreign/military/government accounts.

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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