FDA Medical Device Recalls (openFDA)
Daavlin Distributing Company: Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
- Recall number
- Z-2742-2026
- Recalling firm
- Daavlin Distributing Company
- Product
- Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
- Status
- Open, Classified
- Initiated
- 2026-03-05
- Posted
- 2026-07-15
- Terminated
- not on file
- 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 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
- Quantity
- 2 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Serial Numbers: 4-01440NB10CL, 2 4-01441NB10CL.
- 510(k) numbers
- ["K210881"]
- PMA numbers
- not on file
- Product code
- FTC
- Firm FEI
- 1526255
- Firm city
- Bryan
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28