Spacelabs Xhibit Central Recall for Audio Alarm Loss After Power Failure
Spacelabs Healthcare is recalling Xhibit Central software due to reports of audio alarm loss after power failures or cable disconnections, which could delay alarm recognition.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall involving a medical device where the loss of audio alarms could delay the recognition of critical patient conditions, fitting the criteria for significant injury risk or structural defect.
Plain-English summary
Spacelabs Healthcare, Inc. is recalling Xhibit Central, Model No. 96102, a central monitoring system intended to provide clinicians with central monitoring of adult, pediatric, and neonatal patient data connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. The recall involves 2,197 units distributed worldwide, including the United States (40 states and Puerto Rico) and multiple countries such as Canada. The affected software versions are 1.3.1, 1.3.2, 1.3.3, and 1.3.4.
The recall was initiated after the firm received reports of loss of audio alarm following a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition. The agency has classified this as a Class II recall.
Clinicians and facilities using this equipment should contact Spacelabs Healthcare for instructions on how to address the issue. The recall number is Z-2261-2020.
The recalled product
- Product
- 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.
- Manufacturer
- Spacelabs Healthcare, Inc.
- Affected units
- 2,197
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model No. 96102 Xhibit Central
- Software Versions: 1.3.1
- 1.3.2
- 1.3.3 and 1.3.4
- UDI: 10841522100345
Distribution
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