Linet Americas - AVE 2 Birthing Bed - Class 3 Recall
AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - CARESCAPE ONE - Class 2 Recall
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 5, 2020 Category: Medical Devices Source Type: alerts
EHOB, Inc. - EHOB Waffle Overlay - Class 2 Recall
Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the hospital journey. Through immersion and envelopment, the WAFFLE Overlay is designed to offload the patient and relieve pressure at bony prominences while the unique venting holes allow for air circulation to keep patients cool, dry and comfortable. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 18, 2020 Category: Medical Devices Source Type: alerts
Mediana Co., Ltd. - DIRECT SUPPLY Attendant VITAL SIGNS MONITOR - Class 2 Recall
DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2020 Category: Medical Devices Source Type: alerts
Ventana Medical Systems Inc - VENTANA HE 600 system - Class 2 Recall
Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2020 Category: Medical Devices Source Type: alerts
Umano Medical, Inc. - ook snow,ook snow MH, ook cocoon - Class 2 Recall
AC Powered hospital adjustable bed. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2020 Category: Medical Devices Source Type: alerts
Philips North America, LLC - M4735A HeartStart XL Defibrillator/Monitor - Class 2 Recall
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 29, 2020 Category: Medical Devices Source Type: alerts
Philips North America, LLC - M4735A HeartStart XL Defibrillator/Monitor - Class 2 Recall
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. It must be used by or on the order of a physician. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2020 Category: Medical Devices Source Type: alerts
Philips North America, LLC - HeartStart MRx - Class 2 Recall
HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support or defibrillation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2020 Category: Medical Devices Source Type: alerts
CME America, LLC - CMEAmerica BodyGuard Microset - Class 2 Recall
BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 5, 2020 Category: Medical Devices Source Type: alerts
TeDan Surgical Innovations LLC - Fukushima suction tubes - Class 2 Recall
Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable devices that are connected to the hospital suction system to remove debris and blood from the surgical field. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 2, 2020 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - LATITUDE Programming System - Class 2 Recall
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 4, 2020 Category: Medical Devices Source Type: alerts
Maquet Cardiovascular Us Sales, Llc - Getinge 46Series - Class 3 Recall
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 28, 2020 Category: Medical Devices Source Type: alerts
Maquet Cardiovascular Us Sales, Llc - Getinge 46Series - Class 3 Recall
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 28, 2020 Category: Medical Devices Source Type: alerts
Breas Medical, Inc. - Protective Cover (Part No. 006344) for Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators - Class 2 Recall
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators during transportation, and in hospital, institutional, and home care environments. It can be used while the Vivo ventilators is operating, for example mounted on a wheelchair, in a personal vehicle, or carried by hand. The device is not to be used with the protective cover while positioned in a warm place, such as in direct sunlight or close to...
Source: Medical Device Recalls - February 25, 2020 Category: Medical Devices Source Type: alerts
