Spacelabs Healthcare, Inc. is recalling 434 Xhibit Telemetry Receivers (Model 96280) with software versions 1.4.0 and 1.4.1. These medical devices may experience an unexpected software shutdown and restart, resulting in a total loss of patient monitoring for approximately 1 to 1.5 minutes. If a medical emergency occurs while the system is offline, healthcare staff will not receive notifications, which could lead to critical delays in life-saving treatment. To date, no injuries or incidents have been reported.
The software defect causes the receiver to go offline without warning for up to 90 seconds, during which time clinicians cannot monitor patient data. This loss of visibility could prevent the detection of dangerous clinical events, potentially resulting in patient harm or death due to delayed medical intervention.
Intended to provide monitoring system with patient data.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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