Official recall notice
FDA DeviceClass IINotable
FDA Recall: Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but
- Recall date
- 2026-06-10
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Some of the Calibration/Output Certificates had the outputs reversed.
Recommended action
What to do
368 units
Product description
Some of the Calibration/Output Certificates had the outputs reversed.