Cl ll Retcam3 & Retcam Shuttle

Company:Clarity Medical Systems Inc.
Date of Enforcement Report 3/21/12
Class ll:

PRODUCT
Retcam3 & Retcam Shuttle with version 6.0 software. General ophthalmic imaging including retinal, corneal and external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity (ROP). Screening of Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP. Model number RC3, part number 21-100500; Model number RCS, part number 20-000300. Recall # Z-1099-2012

REASON
Still images extracted from video recordings may be mislabeled as to right and left eye.

RECALLING FIRM/MANUFACTURER
Clarity Medical Systems Inc., Pleasanton, CA, by letter dated February 7, 2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
33 RetCam Shuttles and 20 RetCam3

DISTRIBUTION
Nationwide and Internationally

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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Or just email training@softwarecpr.com for more info.

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15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.