Product Wiki · Recalls · U.S. FDA — Device Enforcement

Signmoidoscope Intended to provide optical visualization of… — recall Z-2075-2016

U.S. FDA — Device Enforcement · United States · 2016-04-06 · Class II

As described by U.S. FDA — Device Enforcement: 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 c

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2075-2016
Date of alert
2016-04-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Pentax Medical Company
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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