Retcam3 & Retcam Shuttle with version 6.0 software recallZ-1099-2012 · Clarity Medical Systems Inc · initiated Feb 2, 2012
Terminated All recalls posted in February 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Clarity Medical Systems Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Still images extracted from video recordings may be mislabeled as to right and left eye.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1099-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 2, 2012
- Posted by the FDA
- Feb 24, 2012
- Recalling firm
- Clarity Medical Systems Inc
- Quantity
- 33 RetCam Shuttles and 20 RetCam 3 - total 53.
- Product code
- HKI
- FDA submissions
- K081858, K090326, K102859
- 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.
Product description
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 (models, lots, serial numbers)
Model number RC3, part number 21-100500; Model number RCS, part number 20-000300.
Other devices under the same FDA submission
1 device cleared under K081858, K090326, K102859 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- RetCam ShuttleNatus Medical Inc · Camera, Ophthalmic, Ac-Powered1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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