FDA recall Z-2744-2026

Daavlin Distributing Company · Class II · device

Product

Photera 600 3-D, 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

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2026-03-05
Report date
2026-07-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bryan, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2744-2026