Z-1009-2019Class II

Olympus PCF-Q180AC Video Colonoscope -

Name: Z-1009-2019 Olympus PCF-Q180AC Video Colonoscope -
Creator: Olympus Corporation of the Americas
Published: 2018-12-17
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2018-12-17 / Terminated

FDA source

Olympus Corporation of the Americas began a recall of Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal... on 2018-12-17. FDA classified it as Class II and gives the reason as "The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1009-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-17
Posted: 2019-03-12
Terminated: 2020-11-18
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Product code: NWB Endoscope, Accessories, Narrow Band Spectrum
Reason for recall: The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
FDA root cause: Under Investigation by firm
Action: Customers were contacted via telephone on 12/17/18. Customers were also sent notification letters on 1/2/19.
Quantity in commerce: 2
Distribution: US Nationwide distribution in the states of CT, IL, MN, MO, and NC.
Product codes and lots: Serial Number 2501374 and 2704914

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1009-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1007-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-12
Z-1008-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-12
Z-1009-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-12
Z-1010-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-12

Product code NWB

K100584Class IIEvis Exeraii 180 SystemOlympus Medical Systems Corporation / cleared 2010-07-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)