Recall Z-2778-2017— Invuity, Inc.

Name: FDA recall Z-2778-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-12

Class II · Terminated

Class II FDA medical device recall by Invuity, Inc., initiated 2017-06-12, terminated 2023-06-28. It names one FDA 510(k) clearance: K162053. Product: INVUITY(R) PhotonBlade(TM), REF PB1. 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..

Recalling firm: Invuity, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-12
Terminated: 2023-06-28
Firm location: San Francisco, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K162053 — PhotonBladeInvuity, Inc.·cleared 2016-09-15

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

INVUITY(R) PhotonBlade(TM), REF PB1

Reason for recall

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.

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