MedWorm: Universities & Medical Training Alerts

Philips Healthcare Inc. - Philips HeartStart XL Defibrillator/Monitor - Class 2 Recall

Medical Device Recalls — Fri, 22 Feb 2013 02:00:09 +0100

Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation (Source: Medical Device Recalls)

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Philips Healthcare Inc. - Philips HeartStart MRx monitor/defibrillators - Class 2 Recall

Medical Device Recalls — Tue, 11 Sep 2012 01:00:27 +0100

Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician (Source: Medical Device Recalls)

Sunquest Information Systems, Inc. - Sunquest Laboratory - Class 2 Recall

Medical Device Recalls — Sat, 08 Sep 2012 01:00:10 +0100

Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: " Patient registration " Order entry and order modification " Specimen collection, verification, suitability, and distribution " Quality assurance checking " Workload recording " Billing charge capture " Standards and controls recording " Test order result inquiry and reporting Organism susc...

Philips Healthcare Inc. - Class 2 Recall

Medical Device Recalls — Thu, 12 Jul 2012 01:00:21 +0100

Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician (Source: Medical Device Recalls)

Arjo, Inc. dba ArjoHuntleigh - Sara Plus Mobile Patient Lifter - Class 2 Recall

Medical Device Recalls — Sat, 07 Jul 2012 01:00:12 +0100

Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair, or from wheelchair to toilet. Sara Plus is also suitable for walking training when the footboard and kneepad are removed. (Source: Medical Device Recalls)

Philips Healthcare Inc. - Philips HeartStart MRx - Class 2 Recall

Medical Device Recalls — Thu, 28 Jun 2012 01:00:10 +0100

Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician (Source: Medical Device Recalls)

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Intel-GE Care Innovations LLC - QuietCare - Class 3 Recall

Medical Device Recalls — Wed, 06 Jun 2012 01:00:14 +0100

Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04 -- Classification Name: System, Environmental Control, Powered. -- Firm on label: Manufacturer Living Independently Group, Inc., A wholly owned subsidiary of General Electric Company, PO Box 1466, New York, NY 10116 USA, 1-866-772-8243 --- The system is a passive behavior-monitoring device. QuietCare uses strategically placed, unobtrusive, passive wireless infrared pyroelectric sensors in the senior's residence to detect their movement. Data from these sensors are sent to a base station that periodically transmits the information to a centralized secure file server through standard phone lines over a toll-free number. Sophisticated algorithms analyze the data, learning each individual's normal pat...

Cardiac Science Corporation - Powerheart AED, CardioVive AED, GE Responder AED, Nihon Kohden CardioLife AED - Class 1 Recall

Medical Device Recalls — Tue, 28 Feb 2012 02:00:08 +0100

Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following models: Powerheart 9300A, 9300E, 9300P, 9390A, 9390E; CardioVive 92532, 92533; Nihon-Kohden 9200G, 9231; and GE Responder 2019198, 2023440 AEDs. The Powerheart AED G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and be able to deliver therapy. The device is intended to be used by personnel who have been trained it is operation. The user should be qualified by training in basic life support or ...

Nellcor Puritan Bennett Inc. (dba Covidien LP) - BIS BILATERAL SENSOR - Class 1 Recall

Medical Device Recalls — Fri, 27 Jan 2012 02:00:13 +0100

BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc. Product Usage: To enable recordings of electrophysiological (such as EEG) signals. The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patient s forehead. BIS technology is used as an adjunct to clinical judgement and training. Reliance on BIS technology alone for intraoperative anesthetic management is not recommended. (Source: Medical Device Recalls)

Heritage Labs International LLC - The National Childrens Study Adult Blood P1 Mother Kit, - Class 2 Recall

Medical Device Recalls — Thu, 12 Jan 2012 02:01:08 +0100

The National Children's Study Adult Blood P1 Mother Kit, Product A2000, Kit #BB5649523, and A2000T (for training), kit #TA0001801, each kit packed in a bag or envelope, 25 kits/shipping carton, each kit contains 2 Triad Medium Alcohol Prep Pads, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies. Blood specimen collection (Source: Medical Device Recalls)

Heritage Labs International LLC - The National Childrens Study Adult Hair Collection Kit/Heritage Labs - Class 2 Recall

Medical Device Recalls — Thu, 12 Jan 2012 02:01:08 +0100

The National Children's Study Adult Hair Collection Kit/Heritage Labs Westat Adult Hair Collection Kit, Product A2225, Kit #BL1301873, and Training Kit, Product A2225T, Kit #TL0000001, each kit packed in a bag or envelope, 50 kits/shipping carton, and contains 2 Triad Medium Alcohol Prep Pads, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies. Blood specimen collection (Source: Medical Device Recalls)

Heritage Labs International LLC - The National Childrens Study Adult Nail Collection Kit/Heritage Labs - Class 2 Recall

Medical Device Recalls — Thu, 12 Jan 2012 02:01:08 +0100

The National Children's Study Adult Nail Collection Kit/Heritage Labs Westat Adult Nail Collection Kit, Product A2250, Kit #BJ0136829, and Training Kit, Product A2250T, Kit #TJ0000001, each kit packed in a bag or envelope, 50 kits/shipping carton, and contains 2 Triad Medium Alcohol Prep Pads, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies. Blood specimen collection (Source: Medical Device Recalls)

Physio Control, Inc. - LIFEPAK 500 AED - Class 2 Recall

Medical Device Recalls — Wed, 27 Jul 2011 01:00:04 +0100

The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient. The LIFEPAK 500 AED is intended for use in the pre-hospital and workplace and community environments. It has been tested to RTCA/DO-160D; "Environmental Conditions and Test Procedures for Airborne Equipment" (refer to Specifications on page 5-15 of the Operating Instructions 3005338-001). The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and have, at a minimum, the following ski...

Philips Healthcare Inc. - Philips Healthcare HeartStart MRx - Class 2 Recall

Medical Device Recalls — Tue, 09 Nov 2010 02:00:09 +0100

HeartStart MRx Defibrillator/Monitor Models: M3535A / M3536A / M3536J / M3536MC The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician (Source: Medical Device Recalls)

Harris Medical Resources - Harris Medical UV Lamp - Class 2 Recall

Medical Device Recalls since July 07, 2006 — Thu, 17 Jun 2010 01:00:04 +0100

Harris Medical UV Lamp; the device does not have a label identifying the name and place of business or manufacturer, packer or distributor. It is packaged with a "Harris UV Lamp Training Manual" (Source: Medical Device Recalls since July 07, 2006)

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Philips Healthcare Inc. - Philips Heartstart MRx Defibrillator Monitor - Class 2 Recall

Medical Device Recalls since July 07, 2006 — Tue, 25 May 2010 01:00:06 +0100

HeartStart MRx Defibrillator Monitor, Model M3535A HeartStart MRx Defibrillator Monitor, Model M3536A The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician (Source: Medical Device Recalls since July 07, 2006)

Philips Healthcare Inc. - Philips Medical HeartStart MRx Defibrillator Monitor - Class 2 Recall

Medical Device Recalls since July 07, 2006 — Sat, 10 Apr 2010 01:00:06 +0100

HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips 14.8-Volt Lithium Ion Battery (ModeI M3538A). The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. (Source: Medical Device Recalls since July 07, 2006)

Hocoma AG - Lokomat-System - Class 2 Recall

Medical Device Recalls since July 07, 2006 — Fri, 08 Jan 2010 02:00:13 +0100

Hocoma Lokomat-System with Pediatric Module Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a, V5.0x. Powered exercise equipment used to apply automated locomoter training for hemiplegic and paraplegic patients. (Source: Medical Device Recalls since July 07, 2006)

Philips Healthcare Inc. - HEARTSTART MRX, MODEL M3535A - Class 2 Recall

Medical Device Recalls since July 07, 2006 — Tue, 10 Nov 2009 02:00:09 +0100

HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. (Source: Medical Device Recalls since July 07, 2006)

Philips Healthcare Inc. - HeartStart MRx Defibrillator/Monitor - Class 2 Recall

Medical Device Recalls since July 07, 2006 — Wed, 03 Jun 2009 01:00:14 +0100

HeartStart MRx Defibrillator/Monitor, M3535A/M3536A Is used for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. (Source: Medical Device Recalls since July 07, 2006)

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Physio Control, Inc. - LIFEPAK CR Plus - Class 2 Recall

Medical Device Recalls since July 07, 2006 — Fri, 31 Oct 2008 01:00:04 +0100

LIFEPAK CR Plus Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA. The battery operated, small portable device is primarily deployed in Public Access Defibrillator (PAD) environments where the expected use for any one device is once every 20 months. Product is capable of 30 full discharges. LIFEPAK CR Plus AEDs are intended for use on victims/patients in cardiac arrest. It includes a patented shock advisory system that notifies the user (i.e. minimally trained responder) if it detects a cardiac rhythm that requires a shock. The individual must be unresponsive (unconscious), not breathing normally, and showing no s...

Physio Control, Inc. - LIFEPAK Express AED - Class 2 Recall

Medical Device Recalls since July 07, 2006 — Fri, 31 Oct 2008 01:00:04 +0100

LIFEPAK Express Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA. The battery operated, small portable device is primarily deployed in Public Access Defibrillator (PAD) environments where the expected use for any one device is once every 20 months. Product is capable of 30 full discharges. LIFEPAK Express AEDs are intended for use on victims/patients in cardiac arrest. It includes a patented shock advisory system that notifies the user (i.e. minimally trained responder) if it detects a cardiac rhythm that requires a shock. The individual must be unresponsive (unconscious), not breathing normally, and showing no si...