Xhibit recallZ-2261-2020 · Spacelabs Healthcare, Inc. · initiated Aug 30, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Spacelabs Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.
FDA root cause category: Software Manufacturing/Software Deployment
What the company is doing
Urgent Medical Device Correction letters were sent to U.S. customers on August 30, 2019 via priority service, and to foreign customers via email on September 6, 2019. The letter informed customers of the conditions under which alarm audio may be lost, and actions the customer /user can take to minimize risk to patients or users. Customers were requested to weigh the benefits versus the risks when deciding whether or not to continue to use Xhibit Central with software versions 1.3.1, 1.3.2, 1.3.3, and 1.3.4. Customers experiencing a loss of audio were informed that a complete reboot of the Xhibit Central will return the device to normal operation. Customers were requested to circulate this notification to all persons affected by the information it contains. Customers were also informed that the manufacturer would contact them to schedule a time for Spacelabs to update their Xhibit Central software. Customers with questions, requiring information, or technical assistance may contact the Technical Support group at Spacelabs Healthcare, Inc. at 1-800-522-7025 and select 2 for Technical Support.
Recall details
- Recall number
- Z-2261-2020
- Status
- Terminated
- Initiated by the company
- Aug 30, 2019
- Recalling firm
- Spacelabs Healthcare, Inc.
- Quantity
- 2197 units
- Product code
- MHX
- FDA submissions
- K122146
- Distribution
- Worldwide distribution - US Nationwide distribution including in the 40 states and Puerto Rico, and multiple countries including Canada.
Product description
Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
Code information (models, lots, serial numbers)
Model No. 96102 Xhibit Central; Software Versions: 1.3.1, 1.3.2, 1.3.3 and 1.3.4; UDI: 10841522100345
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Xhibit 96102Spacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall1 death50 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K122146 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Xhibit Xhibit CentralSpacelabs Healthcare (Washington), Inc · System, network and communication, physiological monitors3 deaths218 reports
- Xhibit Exhibit CentralSpacelabs Healthcare (Washington), Inc · SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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