Z-2743-2026Class II

Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

Name: Z-2743-2026 Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Creator: Daavlin Distributing Company
Published: 2026-03-05
License: https://open.fda.gov/license/

The Daavlin Distributing Co. / initiated 2026-03-05 / Open, Classified / root cause: software

FDA source

Daavlin Distributing Company began a recall of Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders on 2026-03-05. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2743-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-05
Posted: 2026-07-15
Recalling firm: The Daavlin Distributing Co.
Product: Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Product code: FTC Light, Ultraviolet, Dermatological
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).
Root cause tag: software
FDA 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: [email protected]
Quantity in commerce: 26 units
Distribution: US Nationwide distribution.
Product codes and lots: Serial Numbers: 6-09033NB4CL, 6-09037NB4CL, 6-09031NB4CL, 6-09538NB4CL, 6-09038NB4CL, 6-09039NB4CL, 6-09040NB4CL, 6-09041NB4CL, 6-09035NB4CL, 6-09034NB4CL, 6-09030NB4CL, 6-09026NB4CL, 6-09023NB4CL, 6-09028NB4CL, 6-09025NB4CL, 6-09043NB4CL, 6-09029NB4CL, 6-09044NB4CL, 6-09022NB4CL, 6-09027NB4CL, 6-09036NB4CL, 6-09045NB4CL, 6-09024NB4CL, 6-07827NB4CL, 6-09539NB4CL, 6-09042NB4CL.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2743-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2742-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-15
Z-2743-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-15
Z-2744-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-15

Product code FTC

K212510Class II7 Series Phototherapy DeviceDaavlin Distributing Co. / cleared 2021-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)