Home / Recalls / Medical Devices
GE Healthcare, LLC recalls GE Healthcare Carescape Patient Data Module
Recalled October 15, 2014 · FDA recall Z-0060-2015 · GE Healthcare
Hazard
GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform an · FDA Class II
Units
68,452 (39,505 units US, 24,711 units OUS, 4,236 units unidentified/unknown)
Sold at
Worldwide Distribution: US (nationwide) including DC, PR, Guantanamo except DE, HI, ND, SD & WY; and countries of: SOUTH AFRICA, KOREA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, TRINIDAD TOBAGO, THAILAND, TANZANIA, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIA, QATAR, BRASIL, PORTUGAL, POLAND, PHILIPPINES, PERU, PANAMA, PARAGUAY, OMAN, NEW ZEALAND, NORWAY, NETHERLAND, NEPAL, MYANMAR, MEXICO, MOROCCO, MALDOVA, MAURITIUS, MALAYSIA, LITHUANIA, LEBANON, BAHRAIN, KUWAIT, REPUBLIC OF KOREA, JAPAN, JORDAN, JAMAICA, ITALY, ISRAEL, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, GUATEMALA, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT,ECUADOR, DENMARK, CECH REPUBLIC, COSTA RICA, COLOMBIA,, CHINA, CANADA, BULGARIA, BELGIUM BANGLADESH, AUSTRIA, AUSTRALIA, and ARGENTINA.
Description
GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform an
Product
GE Healthcare Carescape Patient Data Module
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →