Pentax Medical Company - Class 2 Recall
Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, 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
Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra 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
Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when indications consistent with the requirement 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
Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trachea and Bronchial Tree. The instrument is introduced via the mouth or the nose, as decided by the physician, 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
Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut 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
Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx, Pharynx and Vocal Cords. The instrument is introduced via the mouth or the nose, as decided by the physician, 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
Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope positioned for access to the Common bile Duct 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
Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, 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
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
GRACIE SQUARE HOSPITAL AMENITY (Sodium Monofluorophosphate) Kit [Anatomy Supply Partners, LLc]
Updated Date: Jun 24, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 24, 2016 Category: Drugs & Pharmacology Source Type: alerts
GE Medical Systems, LLC - GE Healthcare, Discovery IGS 740. - Class 2 Recall
GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 24, 2016 Category: Medical Equipment Source Type: alerts
GE Medical Systems, LLC - GE Healthcare, Discovery IGS 730. - Class 2 Recall
GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 24, 2016 Category: Medical Equipment Source Type: alerts
