Pentax Medical Company Recall: Colonoscope Intended to provide optical visualization of an
Pentax Medical Company Recall: Colonoscope Intended to provide optical visualization of an is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Pentax Medical Company; Product: Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Trac
| Recalling firm | Pentax Medical Company |
|---|---|
| Product | Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam |
| Recall initiated | 20160406 |
| Recall number | Z-2068-2016 |
| Category | device |
| State | NJ |
| Country | United States |
$29/mo
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