Recall Z-0643-2018— Pentax of America Inc
Class II · Terminated
Class II FDA medical device recall by Pentax of America Inc, initiated 2018-02-13, terminated 2020-10-09. It names 2 FDA 510(k) clearances: K161222, K092710. Product: Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) 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: The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy..
- Recalling firm
- Pentax of America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-13
- Terminated
- 2020-10-09
- Firm location
- Montvale, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K161222 — PENTAX MEDICAL ED-3490TK, Video Duodenoscope
- K092710 — PENTAX ED-3490TK, VIDEO DUODENOSCOPE
K-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
Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) 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
The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy.
Data sourced from openFDA. This site is unofficial and independent of the FDA.