FDA Medical Device Recalls (openFDA)
Invuity, Inc.: INVUITY(R) PhotonBlade(TM), REF PB1
- Recall number
- Z-2778-2017
- Recalling firm
- Invuity, Inc.
- Product
- INVUITY(R) PhotonBlade(TM), REF PB1
- Status
- Terminated
- Initiated
- 2017-06-12
- Posted
- not on file
- Terminated
- 2023-06-28
- 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
- Lot, serial or model codes
- All Lot Numbers
- 510(k) numbers
- ["K162053"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3007037347
- Firm city
- San Francisco
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28