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U.S. Department of Health and Human Services

Class 2 Device Recall Retcam3 & Retcam Shuttle with version

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  Class 2 Device Recall Retcam3 & Retcam Shuttle with version see related information
Date Initiated by Firm February 02, 2012
Date Posted February 24, 2012
Recall Status1 Terminated 3 on June 07, 2012
Recall Number Z-1099-2012
Recall Event ID 61180
510(K)Number K081858  K090326  K102859  
Product Classification Camera, ophthalmic, Ac-powered - Product Code HKI
Product Retcam3 & Retcam Shuttle with version 6.0 software.

Clarity Medical Systems, Inc.
5775 W. Las Positas Blvd, Suite 200
Pleasanton, CA 94588

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.
Code Information Model number RC3, part number 21-100500; Model number RCS, part number 20-000300.
Recalling Firm/
Manufacturer		 Clarity Medical Systems Inc
5775 W Las Positas Blvd
Pleasanton CA 94588
Manufacturer Reason
for Recall		 Still images extracted from video recordings may be mislabeled as to right and left eye.
FDA Determined
Cause 2		 Software design
Action Clarity Medical Systems, Inc. sent a Safety Alert letter dated February 7, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed the following : 1. Do not use the video mode until the software has been updated. 2. Install the software update using the enclosed CD. The instructions for installation are also enclosed. This software update will correct the anomaly. 3. If you have extracted still images from video recordings, review all potentially affected patient files to determine if any right eye images are mislabeled as left eye images and/or left eye images are mislabeled as right eye images. If any images are mislabeled, make the appropriate corrections in the annotation section of the affected file. Consider whether there is any diagnostic impact or need to re-irnage the patient. We apologize for the inconvenience. If you have questions or concerns, please contact Clarity at 800-215-6005.
Quantity in Commerce 33 RetCam Shuttles and 20 RetCam 3 - total 53.
Distribution Worldwide Distribution -- USA (nationwide) including the states of TN, MO, TX, FL, NJ and Puerto Rico and countries of Italy, Portugal, Czech Republic, Thailand, Chile, Oman, Hong Kong, Russia, Philippines, Sweden, Finland, Ecuador, Australia and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HKI and Original Applicant = CLARITY MEDICAL SYSTEMS
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