Siemens Medical Solutions USA, Inc - ARTIS icono and ARTIS pheno - Class 2 Recall
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 27, 2021 Category: Medical Devices Source Type: alerts
Welch Allyn Inc Mortara - ELI 380 - Class 2 Recall
ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2021 Category: Medical Devices Source Type: alerts
Welch Allyn Inc Mortara - Surveyor S12/S19 - Class 2 Recall
Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2021 Category: Medical Devices Source Type: alerts
Welch Allyn Inc Mortara - AM12M - Class 2 Recall
AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2021 Category: Medical Devices Source Type: alerts
Welch Allyn Inc Mortara - ELI 280 - Class 2 Recall
ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2021 Category: Medical Devices Source Type: alerts
Covidien Llc - Class 2 Recall
Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas. Product Number: SIGTRSB60AMT (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 14, 2021 Category: Medical Devices Source Type: alerts
CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) (clindamycin palmitate hydrochloride) granule, for solution [Bryant Ranch Prepack]
Updated Date: Fri, 02 Apr 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 2, 2021 Category: Drugs & Pharmacology Source Type: alerts
Stryker Sustainability Solutions - HARMONIC ACE7, Shears with Advanced Hemostasis - Class 2 Recall
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 1, 2021 Category: Medical Devices Source Type: alerts
Philips North America, LLC - SureSigns VM4, VM6, and VM8 patient monitors - Class 2 Recall
Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi"gns VM8 (863066, 863068, 863087, 863088) Model Numbers: 863063,863064,863065,863066,863068,863085,863086, 453564021961,453564021971, 53564022001,453564022041, 53564022081,453564024371, 453564024401,453564024421 453564024441,453564024461, 453564024481 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 31, 2021 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - ARTIS Icono - Class 2 Recall
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 23, 2021 Category: Medical Devices Source Type: alerts
Hitachi Medical Systems America Inc - ALOKA ARIETTA 850SE - Class 2 Recall
Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, Endoscopy clinical applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 20, 2021 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir With Balance Biosurface - Class 1 Recall
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator). (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 18, 2021 Category: Medical Devices Source Type: alerts
CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) (clindamycin palmitate hydrochloride) granule, for solution [Rising Pharmaceuticals, Inc.]
Updated Date: Wed, 10 Mar 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 10, 2021 Category: Drugs & Pharmacology Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - Stationary xray system - Class 2 Recall
Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2021 Category: Medical Devices Source Type: alerts
Smiths Medical ASD Inc. - Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube - Class 2 Recall
Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed for single-patient use up to 5 times. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 24, 2021 Category: Medical Devices Source Type: alerts
