BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393

    Recall: Z-0167-2026 · Initiated September 5, 2025

    Recall

    Recall Number
    Z-0167-2026
    Event Number
    97616
    Firm
    Spacelabs Healthcare, Inc.
    FEI Number
    3010157426
    Product Code
    MHX
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    September 5, 2025
    Posted
    October 16, 2025
    Address
    35301 Se Center St, Snoqualmie, WA, 98065-9216

    Description

    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393

    Reason

    Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.

    Action

    On 09/05/2025, the firm email an "URGENT MEDICAL DEVICE CORRECTION" Letter to customer informing them that the DVI cables which are used for connecting the Qube (91390) or Xprezzon (91393) to the 94267-19, 94267-L19, 94267-L17 and 94267-L15 displays, do not meet the EMI/EMC electrical safety standards specifically for electromagnetic shielding and may pose serious risks to patient safety by interfering with the operation of another device, particularly in environments where electrically sensitive medical devices are in use. Customers are instructed to acknowledge receipt and understanding of this notification and request replacement cables as soon as possible, however no later than 31-Dec-2025. Do not replace cables while a patient is admitted to the monitor to mitigate any potential disruption in active patient monitoring. Any affected cables not currently in use should not be placed into service. For questions and/or assistance with this recall, contact: Spacelabs Technical Support Spacelabs Healthcare, Inc 35301 SE Center Street Snoqualmie, WA 98065 1-800-522-7025 and select 2 for Technical Support Email: [email protected]

    Distribution

    Worldwide - United States Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WY and the countries of AFG, ARE, ARG, AUS, AUT, BGD, BHR, BOL, BRA, BRN, CAN, CHE, CHL, CHN, COL, CRI, CYP, CZE, DOM, DZA, ECU, EGY, ESP, FRA, GBR, GRC, GTM, GUM, HKG, IDN, IND, IRL, IRN, ISR, ITA, JOR, KWT, LBN, MAR, MEX, MYS, NLD, NZL, OMN, PAK, PAN, PER, PHL, PLS, POL, PRI, PRT, PRY, QAT, ROM, SAU, SGP, SLV, SRB, THA, TTO, TUN, TUR, TWN, VNM.

    Quantity

    8179