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Pentax Medical Company

26 recalls •
🏥 Medical Devices
• Categories: Implants & Prosthetics, Other Medical Devices, Diagnostic Equipment, Infusion Pumps

Signmoidoscope Product Usage: 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.

Class I - Dangerous

Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

Colonoscope Product Usage: 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.

Class I - Dangerous

Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Class I - Dangerous

Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

Gastroscope Product Usage: 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.

Class I - Dangerous

Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Class I - Dangerous

Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Class I - Dangerous

Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

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

Class I - Dangerous

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations

Class I - Dangerous

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

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

Class I - Dangerous

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

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

Class I - Dangerous

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details →

Video Duodenoscope

Class I - Dangerous

Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.

Feb 22, 2016 Other Medical Devices Nationwide View Details →

EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

Class I - Dangerous

Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the user.

Jun 12, 2014 Diagnostic Equipment Nationwide View Details →

PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.

Class I - Dangerous

PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.

Sep 16, 2013 Infusion Pumps Nationwide View Details →