BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1154-2014 · Initiated January 24, 2014

    Recall

    Recall Number
    Z-1154-2014
    Event Number
    67470
    Firm
    Clarity Medical Systems Inc
    FEI Number
    3004014430
    Product Code
    HKI
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    January 24, 2014
    Posted
    March 7, 2014
    Terminated
    August 11, 2014
    Address
    5775 W Las Positas Blvd, Suite 200, Pleasanton, CA, 94588-4084

    Description

    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.

    Reason

    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.

    Action

    Urgent Safety Alert letters were sent to Risk Manager and to NICU US consignees via FedEx on 1/24/2014. Template of letters to OUS distributors to be sent on distributors letterhead and sent to device recipients via electronic communication and./or hard copy on 1/24/2014.

    Distribution

    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.

    Quantity

    166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables.