Ohmeda Medical - Giraffe Incubator - Class 2 Recall
Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment for the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%). (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts
Ohmeda Medical - Ohmeda Medical Omnibed - Class 2 Recall
Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer ( warmer ). 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 from the uterus to the external environment (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts
Ohmeda Medical - OhmedaOhio CarePlus Incubator - Class 2 Recall
CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. Most Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. Most incubators can be used in two operating modes: 1. Air Control: The ...
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts
Thayer Medical Corporation - Thayer MiniSpacer Dual Spray MDI Adapter - Class 2 Recall
Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The design of the actuator component o...
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
Roche Diagnostics Operations, Inc. - Cobas b 123 POC system - Class 2 Recall
Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COT~b, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 24, 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
Oculus Innovative Sciences, Inc. - FROWound cleanser/ Dressing, wound, drug - Class 2 Recall
Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions, by maintaining a moist wound and skin environment. General and Plastic Surgery: Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various derma...
Source: Medical Device Recalls - December 15, 2016 Category: Medical Equipment Source Type: alerts
ENVIRONMENTAL ADAPTATION HOT AND HUMID (Aloe Socotrina, Bromium, Carbo Vegetabilis, Carboneum Sulphuratum, Colchicum Autumnale, Elaterium, Gelsemium Sempervirens, Hamamelis Virginiana, Hypothalamus, Iodum, Ipecacuanha, Natrum Sulphuricum, Piper Nigrum, Thyroidinum) Liquid [King Bio Inc.]
Updated Date: Nov 22, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 22, 2016 Category: Drugs & Pharmacology Source Type: alerts
Elekta, Inc. - HexaPOD evo RT System - Class 2 Recall
HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 31, 2016 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics Inc - Siemens RAPEDPoint500 - Class 3 Recall
Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts
Philips Electronics North America Corporation - IntelliVue Patient Monitor - Class 2 Recall
IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 4, 2016 Category: Medical Equipment Source Type: alerts
Ge Healthcare It - Imagecast PACS 3.5 and 3.6 - Class 2 Recall
Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may o...
Source: Medical Device Recalls - July 29, 2016 Category: Medical Equipment Source Type: alerts
Beckman Coulter Inc. - Allegra X5 Centrifuge - Class 2 Recall
Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is designed to separate human samples, including blood and other body fluids, for processing, analysis and in vitro diagnostic testing, as well as non-human body samples and chemicals, including industrial and environmental samples. This centrifuge should be operated by qualified personnel only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 24, 2016 Category: Medical Equipment Source Type: alerts
