Recall Z-2713-2017— Pentax of America Inc
Class II · Terminated
Class II FDA medical device recall by Pentax of America Inc, initiated 2017-01-17, terminated 2018-03-08. It names 2 FDA 510(k) clearances: K092710, K963056. Product: Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.. Reason: Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing..
- Recalling firm
- Pentax of America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-17
- Terminated
- 2018-03-08
- Firm location
- Montvale, NJ, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.
Reason for recall
Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.