GE Healthcare, LLC - Vscan Extend - Class 2 Recall
LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend Sector DICOM, Model Number H41212ZD; e. Vscan Extend Sector USB, Model Number H41212RR; f. Vscan Extend Sector Wi-Fi, Model Number H41212ZC Product Usage: Vscan Extend is a general- purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and flui...
Source: Medical Device Recalls - June 19, 2019 Category: Medical Devices Source Type: alerts
Oakworks Inc - Oakworks Imaging Tables - Class 2 Recall
OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic procedures. These tables are suitable to use for diagnostic x-ray imaging and imaging during therapeutic procedures such as spinal injections, vertebroplasty procedures and other pain management procedures. The CFLU Table is designed for Lithotripsy and Urology procedures. It is intended to be operated by a healthcare professional in a medical...
Source: Medical Device Recalls - May 24, 2019 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - HeartStart MRx Monitor/Defibrillator - Class 2 Recall
HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 31, 2018 Category: Medical Devices Source Type: alerts
Ondamed Inc - Ondamed Biofeedback Device - Class 2 Recall
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - XL Defibrillator - Class 3 Recall
HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AED. When operating in Monitor, Manual Defib, or Pacer Mode, the HeartStart XL+ is suitable for use by healthcare professionals traine...
Source: Medical Device Recalls - March 14, 2018 Category: Medical Devices Source Type: alerts
Oakworks Inc - OAKWORKS Medical Imaging Tables - Class 2 Recall
"OAKWORKS¿ Medical CFPM 300 Imaging Table "OAKWORKS¿ Medical CFPM 301 Imaging Table "OAKWORKS¿ Medical CFPM 400 Imaging Table "OAKWORKS¿ Medical CFPM 401 Imaging Table "OAKWORKS¿ Medical CFPMB 301 Bariatric Imaging Table "OAKWORKS¿ Medical CFUR 301 Urology Table "OAKWORKS¿ Medical CFUR 401 Urology Table "OAKWORKS¿ Medical CFLU 401 Lithotripsy/Urology Table Oakworks¿ Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeu...
Source: Medical Device Recalls - February 24, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - HeartStart MRx Monitor/Defibrillator - Class 1 Recall
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 9, 2018 Category: Medical Devices Source Type: alerts
Acumed LLC - Acumed SlideLoc Anatomic Radial Head System - Class 2 Recall
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems with accessories for anatomical replacement of the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitellum of the distal humerus. The modular heads and stems are single use implantable devices. Each Acumed Slide-Loc Anatomic Radial...
Source: Medical Device Recalls - June 1, 2017 Category: Medical Devices 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
Ohmeda Medical - Infant Warmer System - Class 2 Recall
IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat to smoothen the transition from the uterus to the external environment. They fulfill the same purpose of neonatal incubators but they may be preferred over incubators when total access to the patient is needed or desirable (e.g., surgical procedures, extracorporeal membrane oxygenation, frequent resuscitation, etc.). Most infant radiant warmers can be used in two operating modes: 1. Manual: The clinician sets the appropriate he...
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts
Acumed LLC - 6hole Pubic Symphysis plate - Class 2 Recall
6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured where beneficial to the application, and they are secured to the bone with 3.5mm non-locking screws. The Acumed pelvic ring plate is the Pubic Symphysis Plate. The Acumed Pelvic Plating System is intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fixation. The device is to be implanted by...
Source: Medical Device Recalls - February 15, 2017 Category: Medical Equipment Source Type: alerts
GILLETTE SPORT INVISIBLE TRAINING DAY (Aluminum Zirconium Trichlorohydrex Gly) Stick [The Procter Gamble Manufacturing Company]
Updated Date: Nov 23, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 23, 2016 Category: Drugs & Pharmacology Source Type: alerts
Philips Electronics North America Corporation - HeartStart MRx - Class 2 Recall
HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2016 Category: Medical Equipment Source Type: alerts
MitraClip Delivery System by Abbott: Safety Notice - Reinforcement of Proper Procedures to Operate and Deploy
Abbott requiring training of all MitraClip implanting physicians to ensure continued safe use of the device. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - February 29, 2016 Category: American Health Source Type: alerts
Baxter Healthcare Corp. - Baxter Healthcare Corporation - Class 3 Recall
Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000 mL. The HomeChoice and HomeChoice Pro APD systems are intended to be operated by: -Home patients whose physicians have prescribed this system. Patients, or their caregivers, must have received adequate training to use the system. -Clinicians who are using the system for patients under their care and under a prescription. Clinicians must have received adequate training to use the system. Since drain a...
Source: Medical Device Recalls - November 18, 2015 Category: Medical Equipment Source Type: alerts
