Medical device recalls Moderate risk

Invuity, Inc. recalls INVUITY(R) PhotonBlade(TM), REF PB1

Recall date
June 12, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2778-2017
FDA classification
Class II
Brand / firm
Invuity, Inc.
Sold / distributed
nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

INVUITY(R) PhotonBlade(TM), REF PB1

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