BEUDAMED
    FDA Recall Terminated

    Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.

    Recall: Z-1265-2014 · Initiated March 7, 2014

    Recall

    Recall Number
    Z-1265-2014
    Event Number
    67702
    Firm
    Clarity Medical Systems Inc
    FEI Number
    3004014430
    Product Code
    HKI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 7, 2014
    Posted
    March 20, 2014
    Terminated
    August 11, 2014
    Address
    5775 W Las Positas Blvd, Suite 200, Pleasanton, CA, 94588-4084

    Description

    Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.

    Reason

    One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical components inside the RetCam 3 computer module.

    Action

    The firm, Clarity, sent a "Field Bulletin" dated March 12, 2014 to customers - risk managers and distributors by e-mail on March 12, 2014. They plan to follow this with a second letter on or about March 28, 2014 which will include a second bulletin, replacement bulbs and installation instructions. Clarity stated in the letter to its customers "In the meantime, you may continue to use your RetCAM 3." If you have any question of concerns, please contact Clarity at +1 925 621 322 or email to: [email protected]

    Distribution

    Worldwide Distribution: US (nationwide) to states of: TN, MA, CA, TX, MD,FL, MS, IL, and PA; and to countries of: France, Thailand, Egypt, Mexico, Kuwait, India, Austria,Japan, Sweden, Peru, United Kingdom, Philippines,The Netherlands, China,, UAE,Israel, Germany, Italy.

    Quantity

    234 lamps