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U.S. Department of Health and Human Services

Class 2 Device Recall Photera

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 Class 2 Device Recall Photerasee related information
Date Initiated by FirmMarch 05, 2026
Date PostedJuly 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2742-2026
Recall Event ID 99331
510(K)NumberK210881 
Product Classification Light, ultraviolet, dermatological - Product Code FTC
ProductPhotera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Code Information Serial Numbers: 4-01440NB10CL, 2 4-01441NB10CL.
FEI Number 1526255
Recalling Firm/
Manufacturer		 Daavlin Distributing Company
205 W Bement St
Bryan OH 43506-1264
For Additional Information ContactBob Golding
419-636-6304 Ext. 215
Manufacturer 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).
FDA Determined
Cause 2		Software Design Change
ActionDaavlin 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 in Commerce2 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FTC
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