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U.S. Department of Health and Human Services

Class 2 Device Recall INVUITY PHOTON BLADE

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 Class 2 Device Recall INVUITY PHOTON BLADEsee related information
Date Initiated by FirmJune 12, 2017
Create DateJuly 28, 2017
Recall Status1 Terminated 3 on June 28, 2023
Recall NumberZ-2778-2017
Recall Event ID 77607
510(K)NumberK162053 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductINVUITY(R) PhotonBlade(TM), REF PB1
Code Information All Lot Numbers
Recalling Firm/
Manufacturer
Invuity, Inc.
444 De Haro St
San Francisco CA 94107-2347
For Additional Information ContactSteve Annen
415-655-2143
Manufacturer 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.
FDA Determined
Cause 2
Device Design
ActionOfficial notices were sent to customers via FedEx overnight on 6/14/17. Email notices were sent to the sales personnel 06/12/2017 regarding the return of their trunk stock inventory and asking them to also contact customers who had been sent letters.
Quantity in Commerce1328 units
Distributionnationwide
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEI
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