Z-2072-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2016
- Initiation Date
- April 6, 2016
- Termination Date
- December 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,220 units
Product 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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Code Information
Model #'s FI-10BS, FI-10P2, FI-10RBS, FI-13BS, FI-13P, FI-13RBS, FI-16BS, FI-16RBS, FI-9BS and FI-9RBS