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Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in en...

FDA Recall #Z-1009-2019 — Class II — December 17, 2018

Recall #Z-1009-2019 Date: December 17, 2018 Classification: Class II Status: Terminated

Product Description

Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

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.

Recalling Firm

Olympus Corporation of the Americas — Center Valley, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

2

Distribution

US Nationwide distribution in the states of CT, IL, MN, MO, and NC.

Code Information

Serial Number 2501374 and 2704914

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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