Z-2778-2017 Class II Terminated
FDA device recall Z-2778-2017 was initiated by Invuity, Inc. on June 12, 2017 and is designated Class II. 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. The recall status is terminated (terminated June 28, 2023). Affected quantity: 1328 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 2, 2017
- Initiation Date
- June 12, 2017
- Termination Date
- June 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1328 units
Product Description
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 Pattern
nationwide
Code Information
All Lot Numbers