Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psor
FDA device recall Z-2295-2026 · posted 2026-06-02 · Open, Classified
Recall details
- Recalling firm
- Daavlin Distributing Company
- Reason for recall
- Some of the Calibration/Output Certificates had the outputs reversed.
- Action taken
- An URGENT: MEDICAL DEVICE ADVISORY NOTICE dated 12/11/25 was sent to customers. Dual calibration allows you to treat at the surface (0 ) of the device or at 9 inches (9 ) away. It has come to our attention that some of the Calibration/Output Certificates had the outputs reversed. Actions to be taken by the Customer/User: Talk to your physician regarding treatment plans with the new information listed below. If you have any questions or concerns, please do not hesitate to contact our office at (800) 322-8546. Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. Thank you for your cooperation.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- FTC
- Quantity affected
- 368 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2025-12-10
- Date posted
- 2026-06-02
- Location
- Bryan, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 1 Series Phototherapy Equipment (K220840) | Daavlin Distributing Co. | 2022-04-22 |