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.
Enforcement
- Recall Number
- Z-2072-2016
- Event ID
- 73894
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Pentax Medical Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 6, 2016
- Initiation Date
- April 6, 2016
- Classification Date
- June 28, 2016
- Termination Date
- December 21, 2017
- Address
- 3 Paragon Dr, Montvale, NJ, 07645-1782, United States
Description
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.
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.
Model #'s FI-10BS, FI-10P2, FI-10RBS, FI-13BS, FI-13P, FI-13RBS, FI-16BS, FI-16RBS, FI-9BS and FI-9RBS
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
1,220 units