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Recall Observatory FDA recall evidence

Device product

Olympus Pleuravideoscope, Model LTF-240

Z-1763-2020

March 23, 2020

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 85208
Status
Terminated
Classification
Class II
Quantity
265 total
Official record key
device-enforcement:Z-1763-2020

Official wording

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.

Code information: All Serial numbers

Distribution pattern: US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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