18 results
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57ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Aruba Wireless Network Access Points, Model 65 utilized by the Acuity Central Monitoring System. Welch Allyn Protocol, Inc. Intended for use by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. The system connects to a network of patient monitors to record and analyze physiological data being acquired by the monitors.
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code DSI·May 16, 2011
Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300). The VSM300 can monitor systolic and diastolic noninvasive blood pressure (NIBP), pulse rate, and mean arterial pressure (MAP). Units configured with the appropriate options can also simultaneously monitor temperature and noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and continuously monitor pulse rate. The monitor provides programmable audible and visual alarms and automatic NIBP measurements at selectable intervals.
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code MWI·July 28, 2009
Infant reusable blood pressure cuffs, one tube, male slip luer connector, P/N 2930 , manufactured for Welch Allyn Protocol, Inc. and labeled in part: '***Reusable Blood Pressure Cuffs Infant 50 Cuffs REF 008-0625-00 PROTOCOL SYSTEMS, INC. Beaverton, OR 97008-7107 USA Assembled in Mexico***.'
FDA Recall
Terminated
·GE Medical Systems Information Technologies·March 7, 2001
ViewSonic 19" flat panel LCD display Model VG930M which is used as part of the Welch Allyn Acuity Central Monitoring System. The affected serial numbers are those less than QC2082880001. The ViewSonic 19" flat panel LCD display Model VG930M is used as part of the Welch Allyn Acuity Central Monitoring System (Acuity System.) The Acuity System consists of a central monitoring station, Acuity System software, and a collection of other commercially available networked products
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code DSI·May 1, 2009
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
Propaq LT vital signs monitor, Model 802LTRN
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code MWI·October 22, 2006
Welch Allyn AED 10 Automated External Defibrillator
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code MKJ·December 15, 2008
Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code DSI·December 31, 2003
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code MWI·November 21, 2013
Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code MKJ·February 26, 2009
Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10")
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code MKJ·April 24, 2009
Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code DQA·June 8, 2004
Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code MKJ·December 15, 2008
Propaq LT vital signs monitor, Model 802LTON
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code MWI·October 22, 2006
Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. Designed for use in and out of the hospital.
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code DRO·September 17, 2010
Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo Grove, Illinois; Model AED 20, Catalog Numbers 972213, 972214, 972215, 972216 (Part Numbers 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E)
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code MKJ·August 23, 2007
Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator; Model AED10; Part Numbers: 970302E,970308E,970309E, 970310E and 970311E;
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code MKJ·October 26, 2007
Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code MKJ·December 15, 2008