Recall Z-2778-2017 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Invuity, Inc.
INVUITY(R) PhotonBlade(TM), REF PB1
| Date | Jun 12, 2017 |
| Status | Terminated |
| 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. |
| Root cause | 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 | 1328 units |
| Distribution | nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162053 | PhotonBlade Invuity, Inc., Sep 15, 2016 |