Recall Z-3067-2017— Pentax of America Inc

Name: FDA recall Z-3067-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-23

Class II · Terminated

Class II FDA medical device recall by Pentax of America Inc, initiated 2017-05-23, terminated 2020-05-21. It names 3 FDA 510(k) clearances: K130706, K090196, K061068. Product: Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.. Reason: Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step..

Recalling firm: Pentax of America Inc
Classification: Class II
Status: Terminated
Initiated: 2017-05-23
Terminated: 2020-05-21
Firm location: Montvale, NJ, United States

510(k) clearances named in this recall

3 on FDA's record

K130706 — DUOFLEX COIL SUITE (1.5T)Mr Instruments, Inc.·cleared 2013-07-25
K090196 — EG-3670URKPentax Medical Company·cleared 2009-05-19
K061068 — EG-3670URKPentax Medical Company·cleared 2006-05-03

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

Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

Reason for recall

Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step.

Data sourced from openFDA. This site is unofficial and independent of the FDA.