Home / Recalls / Medical Devices
GE Healthcare, LLC recalls ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry
Recalled October 30, 2019 · FDA recall Z-0175-2020 · GE Healthcare
Hazard
May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions. · FDA Class II
Units
22,438 (17,971 US; 4,467 OUS) devices total
Sold at
Worldwide distribution - US Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. The countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUAM, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, Indonesia, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, Korea (Republic of), KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, Malaysia, MEXICO, MOROCCO, Myanmar, NETHERLANDS, New Zealand, NORWAY, PANAMA, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, Russia, SAUDI ARABIA, Singapore, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TAJIKISTAN, Thailand, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, Viet Nam, YUGOSLAVIA.
Description
May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.
Product
ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →