Ra Medical Systems Recalls PHAROS EX-308 Excimer Lasers Due to Calibration Defect
Ra Medical Systems is recalling 435 PHAROS EX-308 Excimer Lasers because they may calibrate with the iris closed.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Ra Medical Systems is recalling 435 units of the PHAROS EX-308 Excimer Laser. The device is used for UVB phototherapy to treat psoriasis, vitiligo, atopic dermatitis, and leukoderma.
The recall is being issued because there is a possibility that the laser may calibrate with the iris closed. This defect could affect the safety and efficacy of the phototherapy treatment.
The affected units were distributed nationwide in the United States and internationally to Korea, Kuwait, and Saudi Arabia. Consumers and healthcare providers should check their device serial numbers against the list provided by the manufacturer and contact Ra Medical Systems for instructions on how to proceed.
The recalled product
- Product
- PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
- Manufacturer
- Ra Medical Systems Inc
- Category
- Medical Device — Laser Therapy
- Hazard
- Affected units
- 435
Distribution
Distributed nationwide across the United States.
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