Z-2743-2026 Class II Ongoing

Recalled by Daavlin Distributing Company — Bryan, OH

FDA device recall Z-2743-2026 was initiated by Daavlin Distributing Company on March 5, 2026 and is designated Class II. 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). The recall status is ongoing. Affected quantity: 26 units.

Recall Details

Product Type
Devices
Report Date
July 22, 2026
Initiation Date
March 5, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
26 units

Product Description

Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

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).

Distribution Pattern

US Nationwide distribution.

Code Information

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.