Breas Medical, Inc. - Protective Cover (Part No. 006344) for Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators - Class 2 Recall
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators during transportation, and in hospital, institutional, and home care environments. It can be used while the Vivo ventilators is operating, for example mounted on a wheelchair, in a personal vehicle, or carried by hand. The device is not to be used with the protective cover while positioned in a warm place, such as in direct sunlight or close to...
Source: Medical Device Recalls - February 25, 2020 Category: Medical Devices Source Type: alerts
Philips North America, LLC - Philips Ambulance Parameter Extension Kit - Class 2 Recall
Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 22, 2020 Category: Medical Devices Source Type: alerts
Edan Diagnostics - EDAN Telemetry Transmitter, Model iT20 - Class 2 Recall
EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 19, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - CARESCAPE Central Station - Class 2 Recall
CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 21, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - CIC Pro Clinical Information Center Central Station - Class 2 Recall
CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 21, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - ApexPro Telemetry System - Class 2 Recall
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems ...
Source: Medical Device Recalls - December 21, 2019 Category: Medical Devices Source Type: alerts
Ohmeda Medical - Giraffe Omnibed - Class 2 Recall
Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition...
Source: Medical Device Recalls - October 5, 2019 Category: Medical Devices Source Type: alerts
AZIYO BIOLOGICS - BioEnvelope - Class 2 Recall
BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the C...
Source: Medical Device Recalls - October 5, 2019 Category: Medical Devices Source Type: alerts
AZIYO BIOLOGICS - CanGaroo Envelopes - Class 2 Recall
CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body....
Source: Medical Device Recalls - October 5, 2019 Category: Medical Devices Source Type: alerts
CooperSurgical, Inc. - RI Witness Embryology Heated Plate - Class 3 Recall
Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated t...
Source: Medical Device Recalls - October 3, 2019 Category: Medical Devices Source Type: alerts
CLARITY RX - SKIN DEFENSE ENVIRONMENTAL PROTECTION (Octinoxate And Zinc Oxide) Cream [Cosmetic Solutions LLC]
Updated Date: Fri, 27 Sep 2019 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - September 27, 2019 Category: Drugs & Pharmacology Source Type: alerts
Fenwal Inc - VOLUMAT MC AGILIA US - Class 1 Recall
VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV ro...
Source: Medical Device Recalls - August 13, 2019 Category: Medical Devices Source Type: alerts
ASTRA, LLC - Lidar System for Erosion Flume Application Model L1 - Class 2 Recall
Lidar System for Erosion Flume Application Class 1 Laser Product Product Usage: Product is installed and fixed above a dynamic indoor flume designed for modeling water erosion in an indoor research environment with limited human access (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 8, 2019 Category: Medical Devices Source Type: alerts
Xhale Assurance, Inc. - Nasal Alar SpO2 Sensor - Class 2 Recall
Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (at least 4 years and older and weighing > 15kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 31, 2019 Category: Medical Devices Source Type: alerts
Medical Intelligence Medizintechnik Gmbh - IGuide System - Class 2 Recall
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 26, 2019 Category: Medical Devices Source Type: alerts
