Z-1631-2020Class II

Pharos Excimer Laser, Model: EX-308 -

Name: Z-1631-2020 Pharos Excimer Laser, Model: EX-308 -
Creator: Ra Medical Systems, Inc.
Published: 2019-08-23
License: https://open.fda.gov/license/

Ra Medical Systems,Inc / initiated 2019-08-23 / Terminated / root cause: software

FDA source

Ra Medical Systems, Inc. began a recall of 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... on 2019-08-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1631-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-23
Posted: 2020-04-01
Terminated: 2021-05-05
Recalling firm: Ra Medical Systems,Inc
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.
Product code: GEX Powered Laser Surgical Instrument
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.
Root cause tag: software
FDA 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 in commerce: 10
Distribution: U.S. Nationwide distribution in the states of CA, FL, OR, MS, NY.
Product codes and lots: All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1631-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1631-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-04-01

Product code GEX

K062963Class IIPharos Excimer Laser System, Model Ex-308Ra Medical Systems,Inc / cleared 2007-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)