Z-0757-2017Class II

Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical...

Name: Z-0757-2017 Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical...
Creator: Pentax of America Inc
Published: 2016-05-31
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2016-05-31 / Terminated / root cause: manufacturing process

FDA source

Pentax of America Inc began a recall of Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and... on 2016-05-31. FDA classified it as Class II and gives the reason as "The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs that were in use prior to the 2014 clearance, and therefore...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0757-2017
Classification: Class II
Status: Terminated
Initiated: 2016-05-31
Posted: 2016-12-14
Terminated: 2019-08-19
Recalling firm: PENTAX of America, Inc.
Product: Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs that were in use prior to the 2014 clearance, and therefore did not include the cleared Operation and Reprocessing IFUs.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Pentax sent a US Urgent Field Correction letter to all affected customers with a field correction/field safety response form via USPS on May 31, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Revised instructions were as follows: The instructions have been revised in the following manner: Operation IFU o Integrated all models of each family into the IFU o Modified the indications for use language to be consistent with similar products o Enhanced the explanation of the operation of the device o Revised and added cautions and warnings Reprocessing IFU o Included more specificity regarding reprocessing activities to aid in the proper method for reprocessing the endoscopes, including: number of brush and rinse steps, quantity of fluid volumes, use of additional text, figures, cautions, and warnings Identification of Affected Endoscope Models Table 1 provides an overview of the Affected Endoscope models, and the part number and revision of the historical and revised IFUs. The accompanying USB flash drive contains all the revised IFUs identified below. Please distribute only those IFUs which support the products owned by your facility. Table 1 Affected Models Historical Version of IFUs Revised IFUs EB-1970UK Ultrasound Video Bronchoscope Z870 Owners IFU S016_R02 Operator IFU S021_R04 Reprocessing IFU No.388_R01 Addendum No.392_R00 Addendum EB-70K series Video Bronchoscopes Z705 Operation IFU S015_R04 Operator IFU S020_R04 Reprocessing IFU No.388_R01 Addendum No.392_R00 Addendum Z706 Reprocessing IFU EB-75K series Video Bronchoscopes S003 Owners IFU Customers were instructed to ensure that user departments discard the prior versions of the Instructions for Use and ensure that all users read and carefully follow the revised Operation and Reprocessing IFUs to ensure the proper use and cleaning of the affected PENTAX endoscopes. Customers were advised to contact their PEN
Quantity in commerce: 113 units
Distribution: Nationwide Distribution
Product codes and lots: EB-1970UK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0757-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0757-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-14

Product code EOQ

K131946Class IIEntax Ultrasound Video Bronchoscope Eb-1970Uk + Hi Visin PreirusPentax Medical Company / cleared 2014-04-25

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)