PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 19, 2017 Initiated: January 17, 2017 #Z-2713-2017

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.

Details

Recalling Firm
Pentax of America Inc
Units Affected
2,015 (US - 519 (ED-3490TK) and 5 (ED-3270K); OUS - 1,491)
Distribution
Worldwide Distribution-US (Nationwide) including states of: AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI, WV, WY;. and country of: CANADA.
Location
Montvale, NJ

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Pentax of America Inc. Units affected: 2,015 (US - 519 (ED-3490TK) and 5 (ED-3270K); OUS - 1,491).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 19, 2017. Severity: Moderate. Recall number: Z-2713-2017.

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