Recall Z-1099-2012 ยท HKI Camera, Ophthalmic, Ac-Powered
Clarity Medical Systems Inc
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.
| Date | Feb 24, 2012 (initiated Feb 2, 2012) |
| Status | Terminated |
| Reason | Still images extracted from video recordings may be mislabeled as to right and left eye. |
| Root cause | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |