Product Wiki · Recalls · U.S. FDA — Device Enforcement

Xhibit Central, Model No. 96102 — recall Z-2261-2020

U.S. FDA — Device Enforcement · United States · 2019-08-30 · Class II

As described by U.S. FDA — Device Enforcement: 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.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2261-2020
Date of alert
2019-08-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Spacelabs Healthcare, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide distribution - US Nationwide distribution including in the 40 states and Puerto Rico, and multiple countries including Canada.
Barcode (EAN/GTIN)
10841522100345
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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