Spacelabs Healthcare Inc recalls Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patie…

Recall date

February 26, 2016

Source

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

Recall number

Z-1092-2016

FDA classification

Class II

Brand / firm

Spacelabs Healthcare Inc

Sold / distributed

distributed in AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WY and Guam and in the following countries AFGHANISTAN, ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CHILE, CHINA, COLOMBIA, C…

Why it was recalled

The firm has received one report of values for patient height and weight being switched when input at the Xhibit Central Station, Model 96102, causing a bedside monitor Body Surface Area (BSA) calculation to be in error.

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

What was recalled

Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.