BEUDAMED
    FDA Recall Terminated

    Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s5ix Imaging System with s5iz PC Workstation Refurbished, Part#807400001 R and 807401200; (3) s5i Imaging System, Part#806300003; (4) s5i Imaging System, Part#5322466; (5) s5x Imaging System, Part#807300001; (6) s5x Imaging System Refurbished, Pat#807300001 R; (7) s5 Imaging System Refurbished, Part#804200001 R; (8) CORE Mobile Imaging System (120V), Part #400-0100.01; (9) CORE Mobile Imaging System Refurbished, Part #400-0100.01-R; (10) CORE Mobile Imaging System (240V), Part #400-0100.07; (11) CORE Mobile Imaging System Refurbished, Part #400-0100.07-R; (12) CORE Mobile Imaging System (100V), Part #400-0100.08; (13) CORE Mobile Imaging System Refurbished, Part #400-0100.08-R; and (14) CORE Imaging System, Part #400-0100.02; (15) CORE Integrated Imaging System Refurbished, Part#400 0100.02 R.

    Recall: Z-0674-2020 · Initiated November 7, 2018

    Recall

    Recall Number
    Z-0674-2020
    Event Number
    83919
    Firm
    Volcano Corporation
    FEI Number
    2939520
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 7, 2018
    Posted
    December 12, 2019
    Terminated
    July 14, 2022
    Address
    2870 Kilgore Rd, Rancho Cordova, CA, 95670-6133

    Description

    Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s5ix Imaging System with s5iz PC Workstation Refurbished, Part#807400001 R and 807401200; (3) s5i Imaging System, Part#806300003; (4) s5i Imaging System, Part#5322466; (5) s5x Imaging System, Part#807300001; (6) s5x Imaging System Refurbished, Pat#807300001 R; (7) s5 Imaging System Refurbished, Part#804200001 R; (8) CORE Mobile Imaging System (120V), Part #400-0100.01; (9) CORE Mobile Imaging System Refurbished, Part #400-0100.01-R; (10) CORE Mobile Imaging System (240V), Part #400-0100.07; (11) CORE Mobile Imaging System Refurbished, Part #400-0100.07-R; (12) CORE Mobile Imaging System (100V), Part #400-0100.08; (13) CORE Mobile Imaging System Refurbished, Part #400-0100.08-R; and (14) CORE Imaging System, Part #400-0100.02; (15) CORE Integrated Imaging System Refurbished, Part#400 0100.02 R.

    Reason

    Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).

    Action

    The recalling firm issued letters dated 10/26/2018 during the week of 11/7/2018. The letters explain how to detect any potential interoperability and provide details of the impact to the system performance. The letters will be sent via proof of delivery. Field Service Engineers will visit each site to install the software update. Urgent Medical Device Field Action notices, dated 04/27/2020, were mailed to customers during the week of 04/27/2020. Customers informed of the following: If the calibrated device Pa values have a misalignment greater than plus/minus 3mm Hg, contact Technical Support so that the system can be corrected. Additionally, a software update has been developed which will resolve the interoperability issue. The Technical support team will deploy the software update on each impacted system to address the interoperability issue described above. Please ensure that a copy of this letter is provided to all personnel within your organization who handle this device. Customers with additional questions are encouraged to call: 18002284728, Option 2, or email: [email protected]

    Distribution

    Distribution was nationwide. There was government/military distribution. Foreign distribution was made to Canada, Austria, Australia, Badajoz, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Ireland, Israel, Italy, Jordan, Japan, Korea, Republic of, Lebanon, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.

    Quantity

    3,667 units with software