FDA recall Z-2778-2017
Invuity, Inc. · Class II · device
Product
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.
Distribution
nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2017-06-12
- Report date
- 2017-08-02
- Termination date
- 2023-06-28
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- San Francisco, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2778-2017