Retcam3 & Retcam Shuttle with version 6.0 software. Clarity Medical Systems, Inc. 5775 W. Las Positas Blvd, Suite 200 Pl

FDA device recall Z-1099-2012 · posted 2012-02-24 · Terminated

Recall details

Recalling firm

Clarity Medical Systems Inc

Reason for recall

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

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

HKI

Quantity affected

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, Philip

Date initiated

2012-02-02

Date posted

2012-02-24

Date terminated

2012-06-07

Location

Pleasanton, CA

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