FDA Enforcement
Class II
Terminated
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
Recall: Z-2075-2016
·
Reported July 6, 2016
Enforcement
- Recall Number
- Z-2075-2016
- 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
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
Reason
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.
Code Info
Model #'s FS-34V, ES-3831, ES-3870K and ES-3840
Distribution
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Quantity
1,596 units