Class 2 Device Recall Xhibit

• Date Initiated by Firm: June 04, 2026
• Date Posted: August 07, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2916-2026
• Recall Event ID: 99260
• 510(K)Number: K122146
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102. Xhibit offers remote surveillance of patient data for those patients connected to a Spacelabs Healthcare bedside monitors and telemetry systems. The DisplayPort audio/video splitter allows users to extend the audio/video source from the Xhibit to additional external displays or monitors. This extension of audio/video is for viewing only and does not allow interaction with the Xhibit. Component: The DisplayPort audio/video splitter is a 3rd party external accessory to Xhibit.
• Code Information: Model/Catalog Number: 96102 DisplayPort Splitter Part Number: 010-1975-00 UDI-DI codes: 1084152212706 10841522100345 Serial Numbers: Pending
• FEI Number: 3010157426
• Recalling Firm/ Manufacturer: Spacelabs Healthcare, Inc.; 35301 Se Center St; Snoqualmie WA 98065-9216
• For Additional Information Contact: Brad Chen; +1-425-3963300
• Manufacturer Reason for Recall: Due to off-the-shelf display port component that has audio/video failures
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: On 06/04/2026, an "URGENT MEDICAL DEVICE CORRECTION" Letter was emailed to customers informing them that the use of DisplayPort Splitter (PN 010-1975-00) may potentially result in a loss of audio, video, or both audio and video at the local Xhibit Central Station and/or extended displays. Customers are instructed to: 1. Discontinue use Discontinue use of the DisplayPort Splitter, Model number 010-1975-00, or any unapproved splitters that may be used. 2. Notify Inform all relevant personnel within your organization, including any facilities to which you have distributed the affected products. 3. Acknowledge Confirm receipt of this notification by scanning the QR code below and completing the form. Include the model number of splitter that is utilized at the facility, and if it was purchased through Spacelabs Healthcare. (PDF version of the acknowledgement form can be provided upon request) 4. Disposal Dispose of all affected components. 5. Replace Replace the affected DisplayPort Splitters following the proper installation requirements outlined in section 6 and 7 of CSN 077-0722-00. 6. Fill out the Customer Response Form using the link or QR code provided below. Spacelabs has partnered with IQVIA MedTech to coordinate the recall response process. " Link: https://iqvia-response.my.site.com/mt/fca?cid=spacelabsxhibit-av For questions or support - contact Customer Support at 1-800-522-7025 or via website https://spacelabshealthcare.com/support/
• Quantity in Commerce: 6074
• Distribution: Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WY and the countries of CANADA, FRANCE, ITALY, MALAYSIA, THAILAND.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MHX