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Open, Classified

Olympus Uretero-reno videoscope, Model No. URF-V2

FDA Recall Z-1116-2022 · Posted None

Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeNWB
Date Initiated2022-03-25
Product Quantity1

Reason for Recall

The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.

Firm Action

On March 25, 2022, the firm contacted the affected consignee to inform them that certain manufacturing changes by a supplier led to the possibility that a part within the bending section may crack. Olympus repaired the affected URF-V2 unit free of charge.

Root Cause

Process change control

Distribution Pattern

US Nationwide distribution in the state of AZ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172246OLYMPUS URF-V2/V2ROlympus Medical Systems Corp. · 2018-03-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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