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U.S. Department of Health and Human Services

Class 2 Device Recall Pharos Ex308 Excimer Laser System

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  Class 2 Device Recall Pharos Ex308 Excimer Laser System see related information
Date Initiated by Firm August 23, 2019
Date Posted April 01, 2020
Recall Status1 Terminated 3 on May 05, 2021
Recall Number Z-1631-2020
Recall Event ID 85200
510(K)Number K062963  
Product Classification Powered laser surgical instrument - Product Code GEX
Product 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.
Code Information All serial numbers.
Recalling Firm/
Manufacturer		 Ra Medical Systems, Inc.
2070 Las Palmas Dr
Carlsbad CA 92011-1518
For Additional Information Contact Andrew Jackson
877-635-1800
Manufacturer 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.
FDA Determined
Cause 2		 Software change control
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
Quantity in Commerce 10
Distribution U.S. Nationwide distribution in the states of CA, FL, OR, MS, NY.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = RA MEDICAL SYSTEMS, INC.
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