Recall Z-1631-2020 ยท GEX Powered Laser Surgical Instrument
Ra Medical Systems, Inc.
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
| Date | Apr 1, 2020 (initiated Aug 23, 2019) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 10 |
| Distribution | U.S. Nationwide distribution in the states of CA, FL, OR, MS, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062963 | PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 Ra Medical Systems,Inc, Apr 3, 2007 |