Patient monitor

serial #s KVN 0001 through KVN 1071

Cardiovascular Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA WI, WV, WY, and Canada

Physiological Monitoring, Patient Monitor || M31250 Information Center Local Database || Releases A, B, E.01, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PAS-210 Kit Remote Active Speakers. || The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.

Affected model number is 91387 shipped after February 10, 2010 with PCBA 670-1298-01 (serial numbers beginning with 1387-1xxxxx).

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, EGYPT, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PAKISTAN, PANAMA, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, Slovakia, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, Republic OF CHINA, Thailand, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VENEZUELA.AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, EGYPT, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PAKISTAN, PANAMA, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, Slovakia, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, Republic OF CHINA, Thailand, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VENEZUELA.

Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, 90496, & 91496. || Affected model number is 91387 shipped after February 10, 2010 with PCBA 670-1298-01 (serial numbers beginning with 1387-1xxxxx). || The data sheet is labeled in part: || "***91387-27 SL2700 Patient Monitor***91387-28 SL2800 Advanced Patient Monitor***91387-38 SL3800 Central Monitor***Spacelabs Healthcare ***Ultraview SL***The Ultraview SL 2700 and SL2800 bedside monitors include interactive networking, graphic and tabular trends, remote view and alarm watch support. They accommodate two single-high parameter modules, use external flat panel displays, and include a DC power supply that provides power for the monitor and up to three Flexoria¿ system interfaces. The SL3800 central monitor includes interactive networking, graphic and tabular trends, remote view, alarm watch, and central alarm manager. The central monitor accommodates a dual-high recorder module, uses an external flat panel display, and includes a DC power supply. In addition to central monitoring, the SL3800 provides bedside monitoring operation through Biomed-level control***". || Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexport interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. Spacelabs Healthcare patient monitors are intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine: a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Healthcare patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow net worked based applications to open Windows and display information on other net worked monitors. Spacelabs Healthcare patient monitors are also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. Spacelabs Healthcare patient monitors are intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

Cardiovascular Devices

2

No

Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, WI and the countries of UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, SWEDEN, SPAIN, SLOVENIA, SINGAPORE, SAUDI A ARABIA, RUSSIAN FEDERATION, REPUBLIC OF KOREA, PORTUGAL, POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MEXICO, KUWAIT, JAPAN, ITALY, ISRAEL, INDIA, GERMANY, FRANCE, FINLAND, ESTONIA, ECUADOR, DENMARK, CANDA, BELGIUM AUSTRIA, AUSTRALIA, and ALGERIA.

GE Healthcare, DASH 3000, 4000, 5000 Patient Monitors || The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operator's manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK TM indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs.