Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

FDA device recall Z-2742-2026 · posted 2026-07-15 · Open, Classified

Recall details

Recalling firm

Daavlin Distributing Company

Reason for recall

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).

Action taken

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 and press the gear icon in the top right corner of the controller screen c) Select Machine Info d) Select Software Version e) Review Software Information " Confirm the serial number of your device is 123567890abc. The serial number can be found in all the following places: " For devices that remain in the original packaging, it can be found on the outside of the box " For devices that have been removed from the original packaging, it can be found on the back of your machine centered on the top of the Spine Cover or on the bottom of the Spine Cover "Once you confirm your device is identified as an affected device operating ClearLink Controller Software Version 3.17, contact Daavlin Technical Services immediately (see contact information below). Daavlin will place the device into Fixed Calibration Mode as an interim mitigation until ClearLink Controller Software Version 3.18 can be installed. " Complete the enclosed Recall Response Form and return it within 10 business days. Share this notice with all users of this device. " If you distributed the affected device to another facility, immediately provide them with a copy of this notice. " For questions, please contact: Daavlin Technical Services, Phone: (419) 633-3415, Email: rgolding@phothera.com

Root cause

Software Design Change

Status

Open, Classified

Product code

FTC

Quantity affected

2 units

Distribution

US Nationwide distribution.

Date initiated

2026-03-05

Date posted

2026-07-15

Location

Bryan, OH

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