Z-2279-2016Class II

Ultrasound Gastroscope

Name: Z-2279-2016 Ultrasound Gastroscope
Creator: Pentax Medical Company
Published: 2016-04-06
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2016-04-06 / Terminated / root cause: design

FDA source

Pentax Medical Company began a recall of Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper... on 2016-04-06. FDA classified it as Class II and gives the reason as "Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2279-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-06
Posted: 2016-07-23
Terminated: 2017-07-17
Recalling firm: PENTAX of America, Inc.
Product: Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Product code: ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Reason for recall: Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
Root cause tag: design
FDA root cause: Device Design
Action: Pentax Medical sent an "Urgent Field Correction Letter and Response Form" dated April 6, 2016 via Certified Mail to their affected customers. The recall letter identified the product, problem and action to be taken by customer. The customer is asked to complete the response form even if the customers does not have any OS-H2/OS-H4 water bottles to discard. If customer needs assistance in completing the response form, they can contact their local sales representative. For questions regarding the recall, customers can contact Mr. Paul Silva, Pentax Americas Recall Coordinator at: (800) 431-5880 ext. 2064, from (8:30 am - 5:00 pm, Monday - Friday, EST), via fax: (201) 799-4063 or via email to: [email protected].
Quantity in commerce: 819 units
Distribution: US Nationwide Distribution
Product codes and lots: Model #'s EG-3630U, FG-38UX, EG-3630UR, FG-34UX, FG-36UX, EG-3830UT, EG-3670URK and EG-3870UTK.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2279-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2275-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2276-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2277-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2278-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2279-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2280-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22

Product code ODG

K961974Class IIFg-36Ux, Ultrasound Upper Gi FiberscopePentax Precision Instrument Corp. / cleared 1997-02-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)