Z-1213-2024Class II

Colonoscope, Model Number PCF-HQ190L

Name: Z-1213-2024 Colonoscope, Model Number PCF-HQ190L
Creator: Olympus Corporation of the Americas
Published: 2024-01-11
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-01-11 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of Colonoscope, Model Number PCF-HQ190L on 2024-01-11. FDA classified it as Class II and gives the reason as "Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1213-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-11
Posted: 2024-02-29
Recalling firm: OLYMPUS Corporation of the Americas
Product: Colonoscope, Model Number PCF-HQ190L.
Product code: NWB Endoscope, Accessories, Narrow Band Spectrum
Reason for recall: Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On January 11, 2024, the firm notified customers of the issue via URGENT MEDICAL DEVICE REMOVAL letters. Customers were instructed to inspect your inventory and identify any products of the model and lots subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and stop using the device. Customers were given detailed instructions on how to identify affected product. Our Olympus Customer Solutions team will contact you to arrange a no-charge return, and a loaner as necessary. Olympus will perform an inspection of your device, repair the variable stiffness mechanism if required, and return your device at no charge to you. Please acknowledge receipt of this matter through the recall portal at https://olympusamerica.com/recall, Enter the recall number "0437" and complete the form as instructed. Customers who have further distributed product should notify downstream accounts at once. Please report to Olympus any adverse events and/or irregularities with the use of the devices by contacting the Olympus Technical Assistance Center at 1- 800-848-9024, option 1. Adverse events experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. If you have questions about this recall, please contact the recalling firm at (647) 999-3203 or by e-mail at [email protected].
Quantity in commerce: 28
Distribution: US Nationwide distribution.
Product codes and lots: Model Number: PCF-HQ190L; UDI DI: 4953170416118; Serial Number: 2000569, 2001007, 2101185, 2101301, 2101313, 2101860, 2102339, 2102634, 2102740, 2103215, 2103257, 2103483, 2103614, 2103674, 2203899, 2203915, 2204096, 2204400, 2204659, 2204820, 2205238, 2205684, 2206065, 2206501, 2307200, 2307709, 2307713, 2308226;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1213-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1205-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-29
Z-1206-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-29
Z-1207-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-29
Z-1208-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-29
Z-1209-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-29
Z-1210-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-29
Z-1211-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-29
Z-1212-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-29
Z-1213-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-29
Z-1214-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-29

Product code NWB

K192793Class IIEvis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190IOlympus Medical Systems Corp. / cleared 2020-07-17

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)