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Recall Observatory FDA recall evidence

Device product

INVUITY(R) PhotonBlade(TM), REF PB1

Z-2778-2017

June 12, 2017

Class II

Product summary

Firm
Invuity, Inc.
Event
Event 77607
Status
Terminated
Classification
Class II
Quantity
1328 units
Official record key
device-enforcement:Z-2778-2017

Official wording

Reason: A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients.

Code information: All Lot Numbers

Distribution pattern: nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients.