Pentax Medical Company Recall: Signmoidoscope Product Usage: Intended to provide optical v
Pentax Medical Company Recall: Signmoidoscope Product Usage: Intended to provide optical v is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Pentax Medical Company; Product: Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastro
| Recalling firm | Pentax Medical Company |
|---|---|
| Product | Signmoidoscope Product Usage: 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 for recall | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US Nationwide Distribution |
| Recall initiated | 20160406 |
| Recall number | Z-2280-2016 |
| Category | device |
| State | NJ |
| Country | United States |
$29/mo
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