Z-2916-2026Class II
Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A...
GE Healthcare / initiated 2026-06-04 / Open, Classified
Spacelabs Healthcare, Inc. began a recall of Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare... on . FDA classified it as Class II and gives the reason as "Due to off-the-shelf display port component that has audio/video failures". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-2916-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- GE Healthcare
- 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.
- Product code
- MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Reason for recall
- Due to off-the-shelf display port component that has audio/video failures
- FDA 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 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.
- Product codes and lots
- Model/Catalog Number: 96102 DisplayPort Splitter Part Number: 010-1975-00 UDI-DI codes: 1084152212706 10841522100345 Serial Numbers: Pending
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2916-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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