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Class 2 Device Recall Retcam3 & Retcam Shuttle with version |
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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
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Product Classification |
Camera, ophthalmic, Ac-powered - Product Code HKI
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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
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Manufacturer Reason for Recall |
Still images extracted from video recordings may be mislabeled as to right and left eye.
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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
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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.
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510(K) Database |
510(K)s with Product Code = HKI and Original Applicant = CLARITY MEDICAL SYSTEMS
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