Brand Name: Xhibit recallZ-2916-2026 · Spacelabs Healthcare, Inc. · initiated Jun 4, 2026

Why it was recalled

Due to off-the-shelf display port component that has audio/video failures

FDA root cause category: Unknown/Undetermined by firm

What the company is doing

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/

Recall details

Recall number

Z-2916-2026

Recall class

Class II

Status

Open, Classified

Initiated by the company

Jun 4, 2026

Posted by the FDA

Aug 7, 2026

Recalling firm

Spacelabs Healthcare, Inc.

Quantity

6074

Product code

MHX

FDA submissions

K122146

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.

Product description

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.

Other devices under the same FDA submission

3 devices cleared under K122146 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Xhibit Xhibit Central

  Spacelabs Healthcare (Washington), Inc · System, network and communication, physiological monitors
  3 deaths218 reports
• Xhibit 96102

  Spacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  1 recall1 death50 reports
• Xhibit Exhibit Central

  Spacelabs Healthcare (Washington), Inc · SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS
  4 reports