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.
Check against the official notice below — it lists the full affected range.
Spacelabs Healthcare is recalling 2,197 units of the Xhibit Central Model No. 96102, a central monitoring system used by clinicians to monitor patient data for adults, children, and newborns. The recall affects units with software versions 1.3.1, 1.3.2, 1.3.3, and 1.3.4 that were distributed worldwide, including across 40 U.S. states, Puerto Rico, Canada, and multiple other countries.
The company received reports that the device can lose its audio alarm function after a power failure or cable disconnection. This loss of audio on the monitoring system could delay clinicians' recognition of patient alarm conditions. The source document does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide distribution including in the 40 states and Puerto Rico, and multiple countries including Canada. Quantity: 2197 units Lot/code info: Model No. 96102 Xhibit Central; Software Versions: 1.3.1, 1.3.2, 1.3.3 and 1.3.4; UDI: 10841522100345
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.