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Spacelabs Healthcare Inc recalls Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediat
Recalled November 9, 2016 · FDA recall Z-0332-2017 · Spacelabs Healthcare
Hazard
The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally. · FDA Class II
Units
348 units (292 units in the US and 56 units outside the US)
Sold at
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.
Description
The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally.
Product
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.
Manufacturer(s)
Spacelabs Healthcare Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →