Spacelabs Healthcare, Ltd. - Arkon Anesthesia Delivery System - Class 1 Recall
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 11, 2018 Category: Medical Devices Source Type: alerts
Medela Inc - Invia Motion Negative Pressure Wound Therapy System. - Class 2 Recall
Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014) Product Usage: The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by r...
Source: Medical Device Recalls - July 24, 2018 Category: Medical Devices Source Type: alerts
ECOLAB INC - ECOLAB MICROTEK Rolled Probe Cover - Class 3 Recall
ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe). (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 13, 2018 Category: Medical Devices Source Type: alerts
ECOLAB INC - ECOLAB MICROTEK Rolled Probe Cover - Class 3 Recall
ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe). (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 13, 2018 Category: Medical Devices Source Type: alerts
Fort Defiance Industries, LLC - P2131 AUTOMATED FIELD STEAM STERILIZER - Class 2 Recall
FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for use in a variety of austere environments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2018 Category: Medical Devices Source Type: alerts
Intuitive Surgical, Inc. - da Vinci X Surgical System, Model IS4200 - Class 2 Recall
da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablat...
Source: Medical Device Recalls - July 3, 2018 Category: Medical Devices Source Type: alerts
Draegar Medical Systems, Inc. - Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms) - Class 2 Recall
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The ...
Source: Medical Device Recalls - May 15, 2018 Category: Medical Devices Source Type: alerts
Integra LifeSciences Corp. - Manuka Honey Wound Gel - Class 2 Recall
Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 5, 2018 Category: Medical Devices Source Type: alerts
Maquet Cardiopulmonary Ag - Gas Bottle Holder HKH 8880 - Class 2 Recall
CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital patient transport in aircraft and road vehicles (mobile intensive care units and ambulances). Inter-hospital patient transport is transport of the patient between clinics, where the clinical environment is left (e.g., transport in vehicles such as ambulances or aircraft). The gas cylinder holder serves to hold an oxygen cylinder in aircraft. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 5, 2018 Category: Medical Devices Source Type: alerts
Draegar Medical Systems, Inc. - Infinity Acute Care System (lACS) Monitoring Solution - Class 2 Recall
Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professsionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infin...
Source: Medical Device Recalls - April 17, 2018 Category: Medical Devices Source Type: alerts
Medimop Medical Projects Ltd. - Via2BagDirect Connect - Class 2 Recall
Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The device consists of the Vial2Bag piercing spike and cover, the IV Port connector and an integrated Vial Adapter (20mm) for access to the drug/solution vial. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 13, 2018 Category: Medical Devices Source Type: alerts
ZOLL Medical Corporation - Portable Critical Care Ventilator - Class 2 Recall
731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biologic...
Source: Medical Device Recalls - March 2, 2018 Category: Medical Devices Source Type: alerts
Edwards Lifesciences, LLC - HemoSphere Advanced Monitor, HemoSphere SwanGanz Module, and HemoSphere Oximetry Cable - Class 2 Recall
Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HEMSGM10) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It ...
Source: Medical Device Recalls - January 17, 2018 Category: Medical Devices Source Type: alerts
Roche Diagnostics Corporation - cobas 6000 analyzer series, cobas 8000 modular analyzer series, and MODULAR Analytics system - Class 2 Recall
Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and phot...
Source: Medical Device Recalls - January 17, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Physiological Monitoring, Patient Monitor - Class 2 Recall
IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 28, 2017 Category: Medical Devices Source Type: alerts
