BEUDAMED
    FDA Recall Open, Classified

    Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063

    Recall: Z-1848-2022 · Initiated August 26, 2022

    Recall

    Recall Number
    Z-1848-2022
    Event Number
    90818
    Firm
    Leica Microsystems, Inc.
    FEI Number
    3000210133
    Product Code
    FSO
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    August 26, 2022
    Posted
    September 29, 2022
    Address
    10 Parkway North blvd, ste 300, deerfield, IL, 60089-6622

    Description

    Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063

    Reason

    During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.

    Action

    The firm sent a Field Safety Notice to its consignees on 08/26/2022 by mail. The notice described the problem and stated that A Leica Microsystems representative will be contacting the consignee's to arrange this no-cost field update of the instrument. The field update will be scheduled to occur at your convenience within the next 6 months. The notice provided the following workaround: "Advice on action to be taken by the user: " You can continue to use the system pending this field update. Based on our analysis the probability is very remote that an unacceptable patient risk will occur due to the incorrect BrightCare Plus functionality caused by the non-conforming photodiode. " However, please ensure that all users of the affected microscope are aware of the Dangers of Use as described in section 3.4 and will follow the directions in section 5.3 ( Illumination ) and section 8 ( Operation ) of the user manual when handling a surgical operating microscope see excerpts below: o 3.4 Dangers of Use : &do not set the light intensity too high. & because if &light intensity is too high, uncontrolled tissue heating may occur. o 5.3 Illumination : &begin with a low light intensity and increase it until an optimum level of illumination is achieved. o 8 Operation : &use the lowest comfortable light intensity. The notice also requested acknowledgement of receipt of the Field Safety Notice as follows: "Please acknowledge receipt of this Field Safety Notice with the digital acknowledgment form by either scanning the QR code in your mobile phone or with the following link: https://forms.office.com/r/1WPXW93ugL."

    Distribution

    US Nationwide distribution.

    Quantity

    30 devices