FDAFDA · Food and drugs·Recall number Z-2778-2017
INVUITY(R) PhotonBlade(TM), REF PB1
Published August 2, 2017 · Recall initiated: June 12, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Invuity, Inc.
- Distributor
- nationwide
- Lot
- All Lot Numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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