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Recalls & Safety AlertsVersion 6

FDA Records Class II Recall of 212 Photera 600 3-D Phototherapy Units

An FDA enforcement report dated 22 July 2026 lists a nationwide recall by Daavlin Distributing Company over an incorrect UV sensor gain setting affecting calibrated output.

By AI ReporterUpdated Aug 7, 2026, 9:17 a.m. ET
An FDA enforcement report, recall number , records a nationwide U.S. recall of of the Photera 600 3-D phototherapy device, described in the record as an ultraviolet lamp for dermatologic disorders. The record names the recalling firm as , gives an initiation date of 5 March 2026 and a report date of 22 July 2026, and lists the status as . This is a developing matter. The reason given in the enforcement report is that calibrated output was not calculating correctly: the UV sensor GAIN being applied was incorrect, appearing to be "4/5" instead of "7", with counts at approximately 1,000 instead of approximately 5,000. The FDA has classified the action as , which the agency defines as its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The FDA's enforcement database records no other enforcement action by this firm. Equipment of this kind is not a retail item. According to the manufacturer's product and support pages, the Phothera 600-3D is a large full-body phototherapy unit — a frame or cabinet holding an array of ultraviolet fluorescent lamps, run from mains electricity by an attached controller, either a guided dosimetry controller or a digital timer, with software that limits exposure time and logs use. The lamps emit ultraviolet (UVB) light, and the unit is operated only for the exposure periods set by the prescribing clinician's settings. It is a prescription device ordered through a healthcare provider and either installed in a clinic or shipped to an individual patient's home, so those who would have one are clinics and prescribed users rather than retail shoppers. That description is background about the product line and says nothing about this recall. The enforcement record does not state what corrective steps device holders are being asked to take, and no further detail beyond the fields above appears in it.

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Revision history

  1. Version 67 Aug 2026, 13:17current

    Re-verified against the FDA enforcement record; no change to the facts, added full source links for the enforcement report, classification definition and manufacturer product pages.

  2. Version 57 Aug 2026, 12:26

    Replaced the regulatory-code device description with the manufacturer's own product and support descriptions of the Phothera 600-3D, and cited those pages.

  3. Version 47 Aug 2026, 08:22

    Added a paragraph explaining what the device is and how it is supplied, sourced to eCFR and FDA 510(k) records.

  4. Version 37 Aug 2026, 02:53

    Removed the two paragraphs of product-category background not drawn from the enforcement record; added a note that the record does not state corrective actions.

  5. Version 26 Aug 2026, 23:17

    Corrected the product description to the enclosure-style unit documented in the reference sources, added who holds the devices and how they are supplied, and added the supporting source URLs.

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