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FDA Medical Device Recalls (openFDA)

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 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.

Recall number
Z-2916-2026
Recalling firm
Spacelabs Healthcare, Inc.
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.
Status
Open, Classified
Initiated
2026-06-04
Posted
2026-08-07
Terminated
not on file
Reason
Due to off-the-shelf display port component that has audio/video failures
Root 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
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.
Lot, serial or model codes
Model/Catalog Number: 96102 DisplayPort Splitter Part Number: 010-1975-00 UDI-DI codes: 1084152212706 10841522100345 Serial Numbers: Pending
510(k) numbers
K122146
PMA numbers
not on file
Product code
MHX
Firm FEI
3010157426
Firm city
Snoqualmie
Firm state
WA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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