FDA-Device2014-03-19Class II
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
Clarity Medical Systems Inc
Hazard
Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly.
Sold states
Worldwide Distribution-USA (nationwide) including DC and the states of NM, LA, CA, MI, PR, GA, MD, MT, AL, MA, NY, IL, OH, TX, VA, MI, FL, MO, KY, TN, CT, NJ, PA, UT, SD, OK, MS, and NC and the countries of Algeria, Australia, Austria, Bangladesh, Belarus, The Netherlands, Brazil, Bulgaria, Chile, China, Columbia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France,India, Indonesia, Iran, United Kingdom, Israel, Italy, Kuwait, Lebanon, Malaysia, Mexico, Sweden, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Taiwan, Thailand, Turkey, UAE, Argentina, Uzbekistan, Oman, Canada, Germany, and Switzerland.
Affected count
166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables.
Manufactured in
5775 W Las Positas Blvd Suite 200, N/A, Pleasanton, CA, United States
Products
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1154-2014Don't want to check this manually?
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