Pentax Medical Company - Class 2 Recall
Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 29, 2016 Category: Medical Equipment Source Type: alerts
Pentax Medical Company - Class 2 Recall
Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 29, 2016 Category: Medical Equipment Source Type: alerts
Pentax Medical Company - Class 2 Recall
Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 29, 2016 Category: Medical Equipment Source Type: alerts
Pentax Medical Company - Class 2 Recall
Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 29, 2016 Category: Medical Equipment Source Type: alerts
Pentax Medical Company - Class 2 Recall
Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 29, 2016 Category: Medical Equipment Source Type: alerts
Pentax Medical Company - Class 2 Recall
Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 29, 2016 Category: Medical Equipment Source Type: alerts
Pentax Medical Company - Class 2 Recall
Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 29, 2016 Category: Medical Equipment Source Type: alerts
Medtronic Navigation, Inc. - Visualase Cooled Laser Applicator System (VCLAS) - Class 2 Recall
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology. (Sou...
Source: Medical Device Recalls - May 17, 2016 Category: Medical Equipment Source Type: alerts
Covidien LLC - Bravo pH capsule delivery device - Class 2 Recall
Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2016 Category: Medical Equipment Source Type: alerts
Covidien LLC - Bravo pH capsule delivery device - Class 2 Recall
Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2016 Category: Medical Equipment Source Type: alerts
GASTRUNDA (Anacardium Orientale, Argentum Nitricum, Arsenicum Album, Atropinum Sulfuricum, Bismuthum Subnitricum, Condurango Bark, Hamamelis Virginiana, Hydrastis Canadensis, Kalium Bichromicum) Liquid [Seroyal USA]
Updated Date: Apr 18, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 18, 2016 Category: Drugs & Pharmacology Source Type: alerts
Siemens Medical Solutions USA, Inc - CIOS ALPHA - Class 2 Recall
CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 1, 2016 Category: Medical Equipment Source Type: alerts
Adcetris (brentuximab vedotin) for Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
WARNINGS AND PRECAUTIONS
Gastrointestinal Complications
Fatal and serious gastrointestinal (GI) complications... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Xeridiem Mediem Medical Devices Inc - EndoVive 3s Low Profile Balloon Kits - Class 2 Recall
EndoVive 3s Low Profile Balloon Kits Part Number: M00549410 (XMD P/N 70-0050-B22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2016 Category: Medical Equipment Source Type: alerts
Xeridiem Mediem Medical Devices Inc - EndoVive 3s Low Profile Balloon Kits - Class 2 Recall
EndoVive 3s Low Profile Balloon Kits Part Number: M00548970 (XMD P/N 70-0050-G20) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2016 Category: Medical Equipment Source Type: alerts
