Home / Recalls / Medical Devices
Spacelabs Healthcare Inc recalls Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patien
Recalled March 16, 2016 · FDA recall Z-1092-2016 · Spacelabs Healthcare
Hazard
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. · FDA Class II
Units
total 1075 units (614 units in the US and 461 outside the US)
Sold at
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, COSTA RICA, DOMINICAN REPUBLIC, EL SALVADOR, FRANCE, GERMANY, INDIA, IRAN (ISLAMIC REPUBLIC OF), ITALY, KUWAIT, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, and UNITED KINGDOM.
Description
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.
Product
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.
Manufacturer(s)
Spacelabs Healthcare Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →