FDA Recall Terminated

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: Z-0489-2014 · Initiated October 11, 2013

Recall

Recall Number: Z-0489-2014
Event Number: 66970
Firm: GE Healthcare, LLC
FEI Number: 2126677
Product Code: MHX
Status: Terminated
Root Cause: Software design
Initiated: October 11, 2013
Posted: December 12, 2013
Terminated: February 3, 2016
Address: 3000 N Grandview Blvd, Waukesha, WI, 53188-1615

Description

Reason

GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings associated with the B20/B40 V1, B30 and B40 V2 Patient Monitors. The B20, B30 and B40 Patient Monitors set the ECG filter setting incorrectly if the monitor starts with impedance respiration set in the ON position. Instead of the user selected filter, an additional 0.5 Hz high pass filter is used. The

Action

GE Healthcare sent an Urgent Medical Device Correction letter dated October 10, 2013, to all affected consignees. The letter described the safety Issue, Safety Instructions, Affected Product, Details, Product Correction and Contact Information (Technical Support at 1-800-558-7044).Consignees were asked to retain a copy of the instructions with the user manual. For questions regarding this recall call 262-513-4122.

Distribution

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.

Quantity

16,061 (343 US, 15,718 OUS)