Philips Electronics North America Corporation - SureSigns - Class 3 Recall
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 21, 2017 Category: Medical Devices Source Type: alerts
Dukal Corp. - BLUE BURN SHEET - Class 2 Recall
BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2017 Category: Medical Devices Source Type: alerts
Spacelabs Healthcare, Ltd. - Arkon Anesthesia Delivery System and Upgrade Kit 050904300 - Class 1 Recall
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. 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 - November 22, 2017 Category: Medical Devices Source Type: alerts
SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR (Octinoxate, Octocrylene, And Zinc Oxide) Emulsion [SHISEIDO AMERICAS CORPORATION]
Updated Date: Sep 21, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - September 21, 2017 Category: Drugs & Pharmacology Source Type: alerts
SHISEIDO URBAN ENVIRONMENT UV PROTECTION (Octinoxate, Octocrylene, And Zinc Oxide) Cream [SHISEIDO AMERICAS CORPORATION]
Updated Date: Sep 19, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - September 19, 2017 Category: Drugs & Pharmacology Source Type: alerts
SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR (Octinoxate, Octocrylene, And Zinc Oxide) Lotion [SHISEIDO AMERICA INC.]
Updated Date: Sep 15, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - September 15, 2017 Category: Drugs & Pharmacology Source Type: alerts
Certified Safety Mfg Inc - Burn Sheet, sterile 60 x 96 - Class 2 Recall
Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and sold blank. product Usage: Provides sterile environment to protect patient from infection (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 27, 2017 Category: Medical Devices Source Type: alerts
Elekta, Inc. - iGUIDE Software 2.2 - Class 2 Recall
iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 11, 2017 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - MRI - Class 2 Recall
Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of inte...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - MRI - Class 2 Recall
Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest b...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - MRI - Class 2 Recall
Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest bei...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - MRI - Class 2 Recall
Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest bei...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - MRI - Class 2 Recall
Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the reg...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - MRI - Class 2 Recall
1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskel...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - MRI - Class 2 Recall
SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on th...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts
