Xhibit Telemetry Receiver software versions may cause unsolicited system shutdowns
Telemetry receivers with affected software versions may unexpectedly shut down for 1-1.5 minutes, temporarily disabling patient monitoring. This could delay clinical response if a patient event occurs during the outage.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves a software defect that temporarily disables patient monitoring capability. While no illnesses or injuries have been reported, the device failure presents a risk-of-harm scenario where clinical events could occur undetected during the 1-1.5 minute outages.
Plain-English summary
Spacelabs Healthcare is recalling Xhibit Telemetry Receiver systems (Model 96280) with software versions 1.4.0 and 1.4.1, a medical device intended to provide patient data to monitoring systems.
The affected software versions may cause the receiver to unexpectedly shut down and restart, displaying 'Offline' during these events. Each shutdown and restart lasts approximately 1 to 1.5 minutes and results in temporary loss of monitoring capability. If a patient experiences a clinical event during this downtime, staff may not detect it until the system restarts, potentially delaying necessary clinical intervention.
Approximately 434 units have been distributed across the United States, Canada, Taiwan, Czech Republic, France, Greece, Italy, Kuwait, Philippines, and Poland. Healthcare facilities with affected devices should contact Spacelabs Healthcare for information on available software updates or mitigation guidance.
The recalled product
- Product
- Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
- Manufacturer
- Spacelabs Healthcare, Inc.
- Affected units
- 434
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 (2)
- Software Versions: 1.4.0 and 1.4.1. UDI-DI: 10841522107177
- 10841522100246
Distribution
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