Stanley Security Solutions Inc - Arial WaterResistant Pendant, model 59350 - Class 2 Recall
Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts
Del Mar Reynolds Medical, Ltd. - Arkon Anesthesia Delivery System, Model 99999. - Class 2 Recall
Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual ventilation in the event of a power failure scenario. Clinicians are able to use Emergency O2 and manually ventilate the patient, providing gas and agent. However, the anesthesiologist will not have access to mechanical ventilation or ventilator monitoring. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 15, 2017 Category: Medical Equipment Source Type: alerts
ALOCANE EMERGENCY BURN PADS (Lidocaine Hydrochloride) Swab [Quest Products, Inc.]
Updated Date: Mar 8, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 8, 2017 Category: Drugs & Pharmacology Source Type: alerts
Physio-Control, Inc. - LIFEPAK 12 Defibrillator/Monitor - Class 2 Recall
LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 8, 2017 Category: Medical Equipment Source Type: alerts
Physio-Control, Inc. - The LIFEPAK 15 Monitor/Defibrillator (LP15) - Class 2 Recall
LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 8, 2017 Category: Medical Equipment Source Type: alerts
GE OEC Medical Systems, Inc - GE Healthcare Surgery OEC 9800 - Class 2 Recall
OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2017 Category: Medical Equipment Source Type: alerts
GE OEC Medical Systems, Inc - GE Healthcare Surgery OEC 9900 Elite - Class 2 Recall
The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretionOEC 9900 Elite. MDL Numbers: D148942, D155043 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2017 Category: Medical Equipment Source Type: alerts
Physio-Control, Inc. - The LIFEPAK 15 monitor/defibrillator - Class 2 Recall
The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 15, 2016 Category: Medical Equipment Source Type: alerts
Roche Molecular Systems, Inc. - Class 2 Recall
LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). Testing is limited to laboratories certified under the Clinical Labo...
Source: Medical Device Recalls - December 14, 2016 Category: Medical Equipment Source Type: alerts
EMERGENCY FIRST AID EYEWASH PURIFIED WATER (Water) Liquid [Longbow First Aid Products Manufactory]
Updated Date: Dec 8, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 8, 2016 Category: Drugs & Pharmacology Source Type: alerts
Hamilton Medical, Inc. - HamiltonMR1 - Class 2 Recall
Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients within a hospital. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2016 Category: Medical Equipment Source Type: alerts
Spectranetics Corporation - Bridge Occlusion Balloon - Class 2 Recall
Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2016 Category: Medical Equipment Source Type: alerts
CEDERROTH EMERGENCY EYE WASH (Water) Liquid [Orkla Care AB]
Updated Date: Nov 2, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 2, 2016 Category: Drugs & Pharmacology Source Type: alerts
Siemens Medical Solutions USA, Inc - Multix Fusion VA10 Stationary XRay System - Class 2 Recall
Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including:skull, chest, abdomen and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill)applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 5, 2016 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - Multix Fusion Stationary XRay System - Class 2 Recall
Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill)applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 5, 2016 Category: Medical Equipment Source Type: alerts
