|
Product Description
|
Recall Class
|
FDA Recall Posting Date
|
Recalling Firm
|
Z-2065-2016 - 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:...
|
2
|
06/28/2016
|
Pentax Medical Company
|
Z-2080-2016 - 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 mo...
|
2
|
06/28/2016
|
Pentax Medical Company
|
Z-2067-2016 - 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 Bi...
|
2
|
06/28/2016
|
Pentax Medical Company
|
Z-2068-2016 - 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 subsystem...
|
2
|
06/28/2016
|
Pentax Medical Company
|
Z-2069-2016 - 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...
|
2
|
06/28/2016
|
Pentax Medical Company
|
Z-2070-2016 - 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 th...
|
2
|
06/28/2016
|
Pentax Medical Company
|
Z-2071-2016 - 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 subsystem...
|
2
|
06/28/2016
|
Pentax Medical Company
|
Z-2072-2016 - 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 i...
|
2
|
06/28/2016
|
Pentax Medical Company
|
Z-2073-2016 - 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, t...
|
2
|
06/28/2016
|
Pentax Medical Company
|
Z-2074-2016 - 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: ...
|
2
|
06/28/2016
|
Pentax Medical Company
|