Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 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

FDA Recall Z-0168-2026 · Posted 2025-10-16

Recalling FirmSpacelabs Healthcare, Inc.
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2025-09-05
Product Quantity820

Reason for Recall

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.

Firm 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]

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120616SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390Spacelabs Medical, Inc. · 2012-03-29K112962SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)Spacelabs Medical, Inc. · 2011-11-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑