Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the ski
FDA device recall Z-1631-2020 · posted 2020-04-01 · Terminated
Recall details
- Recalling firm
- Ra Medical Systems, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 10
- Distribution
- U.S. Nationwide distribution in the states of CA, FL, OR, MS, NY.
- Date initiated
- 2019-08-23
- Date posted
- 2020-04-01
- Date terminated
- 2021-05-05
- Location
- Carlsbad, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 (K062963) | Ra Medical Systems,Inc | 2007-04-03 |