Ra Medical recalls DABRA Laser (RA-308) systems due to software issues that could cause unintended laser light release, risking user or patient injury. Affected units have serial numbers RA00027 to RA00176.
A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.
Ra Medical is recalling DABRA Laser (RA-:308) systems because a software issue might cause unintended laser light release, potentially injuring users or patients. This affects all units with serial numbers from RA00027 to RA00176.
The software issue may cause the laser to unexpectedly release radiation, which could harm the user or patient. This happens during normal operation when the system is used for surgical procedures.
Medical professionals using the DABRA Laser system for surgical procedures are most at risk. Patients undergoing procedures with this system could also be affected.
Check the serial number on your DABRA Laser system. Affected units have serial numbers from RA00027 to RA00176. All DABRA excimer laser RA-308 products are impacted.
Look for the serial number on your DABRA Laser system to confirm if it falls within RA00027 to RA00176.
Reach out to Ra Medical Systems for guidance on next steps if your unit is affected.
Yes, all DABRA excimer laser RA-308 products are impacted, including those with serial numbers from RA00027 to RA00176.
Check the serial number to see if it falls within RA00027 to RA00176. Contact Ra Medical Systems for further instructions.
The recall states that an unintended release of laser light may occur, potentially injuring the user or patient.
We’ve drafted a message you can send Ra Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2497-2020 — Ra Medical Systems Ra Medical Systems Hello, I own a Ra Medical Systems that is covered by recall Z-2497-2020 from Ra Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
