Home / Recalls / Pentax of America Inc / Z-1267-2020

Z-1267-2020 Class II Terminated

Recalled by Pentax of America Inc — Montvale, NJ

Recall Details

Product Type
Devices
Report Date
February 26, 2020
Initiation Date
January 3, 2020
Termination Date
January 26, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Pentax Video Colonoscope Model: EC34-i10L

Reason for Recall

Distributed in the USA without an approved 510K

Distribution Pattern

NC, MA

Code Information

Serial Numbers: L110300, L110301, L110303, L110306

Other recalls by Pentax of America Inc

  • Z-2329-2025 Class II — Pentax Medical Video Processor; Model Number: EPK-i8020c; (July 16, 2025)
  • Z-1236-2025 Class II — PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (January 29, 2025)
  • Z-1237-2025 Class II — PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (January 29, 2025)
  • Z-1238-2025 Class II — Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscop (January 29, 2025)
  • Z-2449-2021 Class II — Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i (July 14, 2021)
  • Z-2448-2021 Class II — Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument (July 14, 2021)
  • Z-1682-2021 Class II — Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endo (April 21, 2021)
  • Z-0292-2021 Class II — 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), (September 22, 2020)
  • Z-0293-2021 Class II — 9310HD Digital Video Capture Module with software version 3.4.0 or higher config (September 22, 2020)
  • Z-1268-2020 Class II — Pentax Video Colonoscope Model: EC38-i10L (January 3, 2020)