Recall record at a glance
| Official record | Z-0175-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | GE Healthcare, LLC |
| Report date | Oct 30, 2019 |
| Recall initiation date | Aug 30, 2019 |
| Quantity | 22,438 (17,971 US; 4,467 OUS) devices total |
| Location | Waukesha, WI, United States |
Official product description
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.
Why the product was recalled
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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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