FDA-Device2012-12-26Class II
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes.
GE Healthcare, LLC
Hazard
GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.
Sold states
Worldwide distribution, including the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, LA, KS, KY, LA, ME,MD, MA, MI, MN, MS,MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK OR, PA, SC, TN,TX, UT,VA, WA, WT, WY and the countries of the UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAK IA, SINGAPORE, SAUDI ARABIA, QATAR, POLAND, PERU, PANAMA, NORWAY, NEW ZEALAND, NETHERLAND, MEXICO, MALAYSIA, LEBANON, KUWAIT, KOREA, JAPAN, ITALY, INDONESIA, INDIA, IRELAND, GERMANY FRANCE, FINLAND, EGYPT, CZECH REPUBLIC, COSTA RICA, COLOMBIA, CHILE CANADA, BRAZIL, BELGIUM, AUSTRIA, AUSTRALIA, ARGENTINA, and ALGERIA.
Affected count
10,250
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0524-2013Don't want to check this manually?
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