PlainRecalls
FDA Devices Moderate Class II Terminated

Xhibit Central Station, Model 96102. 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.

Reported: November 9, 2016 Initiated: October 18, 2016 #Z-0332-2017

Product Description

Xhibit Central Station, Model 96102. 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 telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally.

Details

Recalling Firm
Spacelabs Healthcare Inc
Units Affected
348 units (292 units in the US and 56 units outside the US)
Distribution
Worldwide Distribution -- USA, to AL, CA, CT, FL, GA, IA, ID, IL, IN, KY, MI, MN, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, WY, and Puerto Rico; and, to the countries of AUSTRALIA, CANADA, CHILE, CZECH REPUBLIC, FRANCE, MEXICO, NETHERLANDS, PANAMA, SAUDI ARABIA, SWITZERLAND, TAIWAN, and UNITED KINGDOM.
Location
Snoqualmie, WA

Frequently Asked Questions

What product was recalled?
Xhibit Central Station, Model 96102. 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.. Recalled by Spacelabs Healthcare Inc. Units affected: 348 units (292 units in the US and 56 units outside the US).
Why was this product recalled?
The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 9, 2016. Severity: Moderate. Recall number: Z-0332-2017.