—#205600

Product

Colonoscope, Model Number CF-H180AL.

FDA product code: NWB — Endoscope, Accessories, Narrow Band Spectrum
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K100584
Affected lot / code info: Model Number: CF-H180AL; UDI DI: 4953170339608; Serial Number: 2001426, 2001524, 2001614, 2002139, 2002212, 2002285, 2103817, 2104137, 2104581, 2105255, 2105976, 2107112, 2207880, 2207929, 2207940, 2309317, 2601078, 2601096, 2601255, 2601368, 2601700, 2702380, 2702460, 2702478, 2702805, 2703697, 2704366, 2704490, 2806996, 2807975, 2900004, 2900185, 2900249, 2908770, 2909110, 2909884;

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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 Cynthia.Ow@Olympus.com.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-01-11
Posted by FDA: 2024-02-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205600. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.