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This page shows you the most recent publications within this specialty of the MedWorm directory.

Philips Healthcare Inc. - Philips HeartStart XL Defibrillator/Monitor - Class 2 Recall
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)
Source: Medical Device Recalls - February 21, 2013 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips HeartStart MRx monitor/defibrillators - Class 2 Recall
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)
Source: Medical Device Recalls - September 10, 2012 Category: Medical Equipment Source Type: alerts

Sunquest Information Systems, Inc. - Sunquest Laboratory - Class 2 Recall
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 assur...
Source: Medical Device Recalls - September 7, 2012 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Class 2 Recall
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)
Source: Medical Device Recalls - July 11, 2012 Category: Medical Equipment Source Type: alerts

Arjo, Inc. dba ArjoHuntleigh - Sara Plus Mobile Patient Lifter - Class 2 Recall
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)
Source: Medical Device Recalls - July 6, 2012 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips HeartStart MRx - Class 2 Recall
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)
Source: Medical Device Recalls - June 27, 2012 Category: Medical Equipment Source Type: alerts

Intel-GE Care Innovations LLC - QuietCare - Class 3 Recall
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 ...
Source: Medical Device Recalls - June 5, 2012 Category: Medical Equipment Source Type: alerts

Cardiac Science Corporation - Powerheart AED, CardioVive AED, GE Responder AED, Nihon Kohden CardioLife AED - Class 1 Recall
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...
Source: Medical Device Recalls - February 27, 2012 Category: Medical Equipment Source Type: alerts

Nellcor Puritan Bennett Inc. (dba Covidien LP) - BIS BILATERAL SENSOR - Class 1 Recall
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)
Source: Medical Device Recalls - January 26, 2012 Category: Medical Equipment Source Type: alerts

Heritage Labs International LLC - The National Childrens Study Adult Blood P1 Mother Kit, - Class 2 Recall
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)
Source: Medical Device Recalls - January 11, 2012 Category: Medical Equipment Source Type: alerts

Heritage Labs International LLC - The National Childrens Study Adult Blood P1 Mother Kit, - Class 2 Recall
The National Children's Study Adult Blood T1 Mother Kit/Heritage Labs Westat T1 Mother Blood Kit, Product A2010, Kit #BA0057371, and Training Kit, A2010T, Kit #TA0000151, each kit packed in a bag or envelope, 25 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)
Source: Medical Device Recalls - January 11, 2012 Category: Medical Equipment Source Type: alerts

Heritage Labs International LLC - The National Childrens Study Adult Hair Collection Kit/Heritage Labs - Class 2 Recall
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)
Source: Medical Device Recalls - January 11, 2012 Category: Medical Equipment Source Type: alerts

Heritage Labs International LLC - The National Childrens Study Adult Nail Collection Kit/Heritage Labs - Class 2 Recall
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)
Source: Medical Device Recalls - January 11, 2012 Category: Medical Equipment Source Type: alerts

Physio Control, Inc. - LIFEPAK 500 AED - Class 2 Recall
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 In...
Source: Medical Device Recalls - July 26, 2011 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips Healthcare HeartStart MRx - Class 2 Recall
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)
Source: Medical Device Recalls - November 8, 2010 Category: Medical Equipment Source Type: alerts

Harris Medical Resources - Harris Medical UV Lamp - Class 2 Recall
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)
Source: Medical Device Recalls since July 07, 2006 - June 16, 2010 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips Heartstart MRx Defibrillator Monitor - Class 2 Recall
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)
Source: Medical Device Recalls since July 07, 2006 - May 24, 2010 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips Medical HeartStart MRx Defibrillator Monitor - Class 2 Recall
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)
Source: Medical Device Recalls since July 07, 2006 - April 9, 2010 Category: Medical Equipment Source Type: alerts

Hocoma AG - Lokomat-System - Class 2 Recall
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)
Source: Medical Device Recalls since July 07, 2006 - January 7, 2010 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - HEARTSTART MRX, MODEL M3535A - Class 2 Recall
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)
Source: Medical Device Recalls since July 07, 2006 - November 9, 2009 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - HeartStart MRx Defibrillator/Monitor - Class 2 Recall
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)
Source: Medical Device Recalls since July 07, 2006 - June 2, 2009 Category: Medical Equipment Source Type: alerts

Physio Control, Inc. - LIFEPAK CR Plus - Class 2 Recall
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. mini...
Source: Medical Device Recalls since July 07, 2006 - October 30, 2008 Category: Medical Equipment Source Type: alerts

Physio Control, Inc. - LIFEPAK Express AED - Class 2 Recall
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. minim...
Source: Medical Device Recalls since July 07, 2006 - October 30, 2008 Category: Medical Equipment Source Type: alerts