Spacelabs Healthcare Inc recalls Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric…

Recall date

October 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0332-2017

FDA classification

Class II

Brand / firm

Spacelabs Healthcare Inc

Sold / distributed

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, a…

Why it was recalled

The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.