INVUITY(R) PhotonBlade(TM), REF PB1
FDA Recall Z-2778-2017 · Posted None
Recalling FirmInvuity, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2017-06-12
Date Terminated2023-06-28
Product Quantity1328 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.