Recall Z-2742-2026 ยท FTC Light, Ultraviolet, Dermatological
Daavlin Distributing Company
Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
| Date | Jul 15, 2026 (initiated Mar 5, 2026) |
| Status | Open, Classified |
| Reason | Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000). |
| Root cause | Software Design Change |
| Action | Daavlin Distributing Company initially notified its consignees about the issue beginning on 3/5/2026 via telephone following with by an email. The firm a follow up URGENT MEDICAL DEVICE Advisory notice on 4/9/2026 with the same information via US mail and email. On 7/10/2026 the firm sent an URGENT MEDICAL DEVICE RECALL notice to all non-responding consignees. The notice explained the issue, potential risk to health, and requested the following: "" Verify your device is operating ClearLink Controller Software Version 3.17 as follows: a) Ensure your machine is plugged in and on b) Locate |
| Quantity | 2 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210881 | M Series Phototherapy Equipment Daavlin Distributing Co., Jun 22, 2021 |