HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor B20 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor B20 is not intended for use during MRI. The PROCARE Monitor B20 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, EGG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esosophageal/Nasopharyngeal/Tymnpanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myo cardial/Core/Surface temperature, and functional oxygen saturation (Sp0 2) and pulse rate via continuous monitoring , including monitoring during conditions of clinical patient motion or low perfusion. K120598 (Procare Monitor B40): The PROCARE Monitor 840 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor 840 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor 840 is not intended for use during MRI. The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympaiic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/ Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion. K130584 (Monitor B40): The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI. The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network. The Monitor B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/ Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy. Product Quantity Distributed (Int) 16,061 (343 US, 15,718 OUS)

Recall details

Manufacturer

GE Healthcare, LLC

Distributor

Worldwide Distribution - USA (nationwide) to CA, CT, FL, GA, MO, NC, NJ, PA, TX, WI and Internationally to: FRANCE, PORTUGAL, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BARBADOS, BELGIUM, BOLIVIA, BOSNIA 7 HERZEGOVINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, NEW ZEALAND, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, COTE DLVOIRE, CROATIA, CYPRUS,. CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, GABON, GERMANY, GREECE, GUATEMALA, HONDURAS, HUNGARIA, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, MYAMMARA, NAMBIA, NAPAL, NETHERLANDS, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL ROMANIA, RUSSIA, SENEGAL SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SIR LANKA, SWEDEN, SWITZERLAND, THAILAND, THE NETHERLANDS, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES , UNITED KINGDOM, URUGUAY, UZEBEKISTAN, VENEZUELA, and VIETNAM.

Lot

Mfg Lot or Serial # SG212501463WA SG213142063WA SG212491284WA SG212491286WA SG212491320WA SG212491328WA SG213091890WA SG213142034WA SG213142065WA SG213172123WA SG213172126WA SG213172141WA SF311283756WA SF312205556WA SG212190622WA SG212190623WA SG212190624WA SG212190625WA SG212190626WA SG212190627WA SG212190628WA SG212190629WA SG212190630WA SG212190631WA SG212160603WA SG212160606WA SG212230660WA SG212260716WA SG212260735WA SG212260737WA SG212260739WA SG212270742WA SG212270747WA SG212491329WA SG212491346WA SG212421031WA SG212431128WA SG212421034WA SG213021574WA SG213031688WA SG212521557WA SG212521545WA SF312396183WA SF312396187WA SF312396189WA SF312396190WA SF312396191WA SF312396192WA SF312396193WA SG213142038WA SG212521547WA SG213021582WA SG213021585WA SG213031681WA SG213031683WA SG213031684WA SG213031685WA SG213031687WA SG213031689WA SF310200786WA SF310200788WA SG212521544WA SG212521546WA SG212521548WA SG212521549WA SG212521550WA SG212521551WA SG212521552WA SG212521553WA SG212521554WA SG212521555WA SG212521556WA SG212521558WA SG212521559WA SG212521560WA SG212521561WA SG212521563WA SG212521564WA SG212521565WA SG213021570WA SG213021571WA SG213021572WA SG213021573WA SG213021575WA SG213021576WA SG213021577WA SG213021579WA SG213021580WA SG213021581WA SG213021583WA SG213021584WA SG213021612WA SG213021614WA SG213021615WA SG213021617WA SG213021618WA SG213021619WA SG213021620WA SG213021621WA SG213021622WA SG213021626WA SG213021627WA SG213021630WA SG213031631WA SG213031632WA SG213031634WA SG213041690WA SG213041691WA SG213041692WA SG213041709WA SG213041712WA SG213041714WA SG213041715WA SG213041723WA SG213041724WA SG213041725WA SG213041726WA SG213041727WA SG213041728WA SG213041729WA SG213041730WA SG213041731WA SG213041732WA SG213041733WA SG213041734WA SG213101906WA SG213132003WA SG213132015WA SG213142039WA SG213142040WA SG213142041WA SG213142042WA SG213142044WA SG213142045WA SG213142046WA SG213142049WA SG213142051WA SG213142055WA SG213142057WA SG213142058WA SG213142060WA SG213142064WA SG213142066WA SG213142067WA SG213142069WA SG213142070WA SG213142071WA SG213142072WA SG213142073WA SG213142074WA SG213142075WA SG213142076WA SG213142077WA SG213142078WA SG213142079WA SG213142080WA SG213142081WA SG213142082WA SG213142083WA SG213142084WA SG213142085WA SG213142087WA SG213142092WA SG213142093WA SG213142096WA SGF12515079WA SGF12515082WA SGF12515093WA SGF13025268WA SGF13025274WA SGF13025278WA SGF13025282WA SGF13025283WA SGF13025284WA SGF13025289WA SGF13025297WA SGF13025298WA SGF13025300WA SGF13025301WA SGF13025303WA SGF13025304WA SGF13025305WA SGF13025306WA SGF13025307WA SGF13025308WA SGF13025309WA SGF13025310WA SGF13025311WA SGF13025312WA SGF13025313WA SGF13025314WA SGF13025315WA SGF13025317WA SGF13025318WA SGF13025319WA SGF13025320WA SGF13025321WA SGF13025322WA SGF13025323WA SGF13025324WA SGF13025325WA SGF13025326WA SGF13025327WA SGF13025328WA SGF13025329WA SGF13025330WA SGF13025331WA SGF13025332WA SGF13025333WA SGF13025334WA SGF13025335WA SGF13025336WA SGF13025337WA SGF13025338WA SGF13025339WA SGF13025340WA SGF13035372WA SGF13035373WA SGF13035374WA SGF13035375WA SGF13045480WA SGF13045481WA SGF13045482WA SGF13045483WA SGF13045484WA SGF13045486WA SGF13045487WA SGF13045488WA SGF13045489WA SGF13045490WA SGF13045491WA SGF13045492WA SGF13045493WA SGF13045494WA SG213031668WA SG213031669WA SG213031670WA SG213031671WA SG213031672WA SG213031673WA SG213031674WA SG213031675WA SG213031676WA SG213031677WA SG213031678WA SG213031680WA SG213031682WA SG213031686WA SGF13025316WA SGF13025341WA SGF13025342WA SGF13025343WA SGF13035434WA SGF13035435WA SGF13035437WA SGF13035439WA SGF13035440WA SGF13035441WA SGF13035442WA SGF13035443WA SGF13035444WA SGF13035445WA SGF13035446WA SG212521562WA SG213021578WA SG21

Risk classification

Class II

Area (FDA)

device

Country

United States