Ambu Inc. - Ambu AuraGain Single Use Laryngeal Mask Sterile - Class 2 Recall
Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2016 Category: Medical Equipment Source Type: alerts
Cardiac Science Corporation - 9131 Defibrillator Electrodes - Class 2 Recall
9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging. The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient ...
Source: Medical Device Recalls - March 10, 2016 Category: Medical Equipment Source Type: alerts
Oxylog 2000 Plus, 3000, and 3000 Plus Emergency Transport Ventilators by Dräger Medical: Class I Recall - System Error May Lead to a Halt in Ventilation Therapy
If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - February 10, 2016 Category: American Health Source Type: alerts
Philips Electronics North America Corporation - TraumaDiagnost - Class 2 Recall
Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2016 Category: Medical Equipment Source Type: alerts
Draeger Medical, Inc. - Emergency Transport Ventilator - Class 1 Recall
Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 4, 2016 Category: Medical Equipment Source Type: alerts
Draeger Medical, Inc. - Emergency Transport Ventilator - Class 1 Recall
Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 4, 2016 Category: Medical Equipment Source Type: alerts
Mercury Enterprises, Inc. dba Mercury Medical - Mercury Medical NeoTee - Class 2 Recall
Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2016 Category: Medical Equipment Source Type: alerts
Thornhill Research Inc - Portable Life Support System - Class 1 Recall
MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities. The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2016 Category: Medical Equipment Source Type: alerts
Thornhill Research Inc - Portable Life Support System - Class 1 Recall
MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2016 Category: Medical Equipment Source Type: alerts
Steris Corporation - AMSCO WARMING CABINET - Class 2 Recall
AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 7, 2016 Category: Medical Equipment Source Type: alerts
Vidco, Inc. - Remote Patient Monitoring System - Class 2 Recall
Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU, CCU, PACU, Emergency, Telemetry Step-down and other areas where patient's physiological information are to be observed at one or more locations. Typical information displayed includes ECG and blood pressure waveforms and numeric values which as heart rate and systolic, mean and diastolic pressure. This device acts as the Central Monitor Statio...
Source: Medical Device Recalls - January 5, 2016 Category: Medical Equipment Source Type: alerts
Shimadzu Medical Systems - MobileDaRt Evolution - Class 2 Recall
Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 19, 2015 Category: Medical Equipment Source Type: alerts
DeRoyal Industries Inc - Various DeRoyal Surgical Kits - Class 2 Recall
DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7959.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02 GEO-MED sterile custome surgical kits: 1) Open Heart Pack Pgybk, ref 89-5792.10 2) Open Heart A&B Pgybk, ref 89-7626.02 3) Open Heart A&B Pgybk, ref 89-7626.03 4) Open Heat Pack A&B Pgybk, ref 89-8440.01 5) Open Heart Pack A&B Pgybk, ref 89-8440.02 (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 3, 2015 Category: Medical Equipment Source Type: alerts
Pyng Medical Corporation - MATResponder Tourniquet - Class 2 Recall
MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet devices. The device provides for emergency blood flow occlusion to the limbs (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 6, 2015 Category: Medical Equipment Source Type: alerts
Lifeline Systems, Incorporated - Philips GoSafe Mobile Help Button 7000MHB - Class 2 Recall
Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2015 Category: Medical Equipment Source Type: alerts
