Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The excimer laser system produces collimated 308 nm radiation, within the invisible region of the electromagnetic spectrum. The UV radiation falls within the range of ultraviolet B (UVB), which is used to treat photo-responsive skin disorders.
FDA Recall Z-1631-2020 · Posted 2020-04-01
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Recalling FirmRa Medical Systems, Inc.
Recall StatusTerminated
Product CodeGEX
Date Initiated2019-08-23
Date Terminated2021-05-05
Product Quantity10
Reason for Recall
At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer laser phototherapy system causes the device to fail to cease firing as long as the foot pedal or handpiece switch is depressed. This malfunction can cause overtreatment, which could result in strong erythema, and possibly cause blisters.
Firm Action
On 08/23/2019, Medical Device Correction was mailed to customers. Customers were informed that the recalling firm's service department would contact them to replace the software. Unitl the software is replaced, do not use doses less than 100 mJ. During service visits customers were informed that software was updated to 1.06 ZRPL
Root Cause
Software change control
Distribution Pattern
U.S. Nationwide distribution in the states of CA, FL, OR, MS, NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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