ClearanceBrief
Recall Z-2916-2026 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Spacelabs Healthcare, Inc.

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 e

DateAug 7, 2026 (initiated Jun 4, 2026)
StatusOpen, Classified
ReasonDue to off-the-shelf display port component that has audio/video failures
Root causeUnknown/Undetermined by firm
ActionOn 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 produc
Quantity6074
DistributionWorldwide - 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K122146XHIBIT CENTRAL STATION, MODEL 96102
Spacelabs Healthcare, Apr 22, 2013