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Recall Observatory FDA recall evidence

Device product

Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS

Z-1187-2019

March 08, 2019

Class II

Product summary

Firm
Gyrus ACMI, Inc.
Event
Event 82451
Status
Terminated
Classification
Class II
Quantity
161
Official record key
device-enforcement:Z-1187-2019

Official wording

Reason: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

Code information: All lot numbers

Distribution pattern: Nationwide Foreign: Germany,Japan, Singapore

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades