FDA recall Z-2261-2020

Spacelabs Healthcare, Inc. · Class II · device

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.

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.

Key facts

Status
Terminated
Initiation date
2019-08-30
Report date
2020-06-10
Termination date
2024-04-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Snoqualmie, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2261-2020