BEUDAMED
    FDA Enforcement Class II Ongoing

    Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines with vertical direction of view

    Recall: Z-0697-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0697-2021
    Event ID
    86707
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Haag-Streit USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2020
    Initiation Date
    November 20, 2020
    Classification Date
    December 23, 2020
    Address
    3535 Kings Mills Rd, N/A, Mason, OH, 45040-2303, United States

    Description

    Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines with vertical direction of view

    Reason

    Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye

    Code Info

    Floor stands FS 2-11, FS 2-15 with the software REF 615 588 in versions 2.0 to 3.3. FS 2-11 Ref. # 615H511 Serial Numbers:From 1001; FS 2-15 Ref. #615H515 Serial Numbers From 1001; HS Hi-R NEO 900 Ref. # 657 Serial Numbers 820 from 101; HS Hi-R NEO 900A Ref # 657 821 Serial Numbers from 101 Unique Device Identifier (UDI) HS Hi-R NEO 900 +EMWM657 820 0/$+serial no. HS Hi-R NEO 900A +EMWM657 821 0/$+serial no. FS 2 11 +EMWM 615H5110/$+serial no. FS 2-15 +EMWM 615H515 0/$+serial no.

    Distribution

    US Nationwide distribution in the state of OK.

    Quantity

    3 units US