Recall Z-2079-2016— Pentax Medical Company
Class II · Terminated
Class II FDA medical device recall by Pentax Medical Company, initiated 2016-04-06, terminated 2017-12-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..
- Recalling firm
- Pentax Medical Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-06
- Terminated
- 2017-12-21
- Firm location
- Montvale, NJ, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.