Date Initiated by Firm | June 12, 2017 |
Create Date | July 28, 2017 |
Recall Status1 |
Terminated 3 on June 28, 2023 |
Recall Number | Z-2778-2017 |
Recall Event ID |
77607 |
510(K)Number | K162053 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product | INVUITY(R) PhotonBlade(TM), REF PB1 |
Code Information |
All Lot Numbers |
Recalling Firm/ Manufacturer |
Invuity, Inc. 444 De Haro St San Francisco CA 94107-2347
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For Additional Information Contact | Steve 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 |
Action | Official 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 Commerce | 1328 units |
Distribution | nationwide |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = GEI
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