Mar

2014

Cl II RetCam

Company:Elekta, Inc.
Date of Enforcement Report:3/19/2014
Class lI:

PRODUCT

RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging. RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
Recall Number Z-1154-2014

REASON
Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly..

RECALLING FIRM/MANUFACTURER
Clarity Medical Systems Inc., Pleasanton, CA. on 1/24/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables.

DISTRIBUTION
Nationwide and Internationally

___________________________________

About the author

Amy Sellers

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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Amy Sellers

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