Recall Z-1763-2020— Olympus Corporation of the Americas

Name: FDA recall Z-1763-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-23

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2020-03-23, terminated 2021-11-30. It names one FDA 510(k) clearance: K013617. Product: Olympus Pleuravideoscope, Model LTF-240. Reason: There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2020-03-23
Terminated: 2021-11-30
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K013617 — LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTSOlympus Optical Co., Ltd.·cleared 2002-01-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Olympus Pleuravideoscope, Model LTF-240

Reason for recall

There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided.

Data sourced from openFDA. This site is unofficial and independent of the FDA.