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Use caution Medical device recall · FDA · Published January 23, 2020

Ra Medical DABRA Laser Recall: Software Issue May Cause Injury

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.

🇺🇸 FDA recall #Z-2497-2020Medical deviceRa Medical Systems ›
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Contact the company

Recalling firmRa Medical Systems, Inc.2070 Las Palmas Dr · Carlsbad, CA 92011-1518
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/65956-ra-medical-dabra-laser-recall-software-issue-may-cause-injury.

Source Summary by GovInfoNow · govinfonow.com/recall/65956-ra-medical-dabra-laser-recall-software-issue-may-cause-injury · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2497-2020

Cite this page

“Ra Medical DABRA Laser Recall: Software Issue May Cause Injury.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65956-ra-medical-dabra-laser-recall-software-issue-may-cause-injury. Based on FDA recall #Z-2497-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2497-2020%22&limit=1).

Ra Medical Systems, Inc. voluntarily recalled the DABRA Laser (RA-308 Excimer Laser) on Jan. 23, 2020, according to the FDA. A software issue could cause unintended laser light release, injuring users or patients.

How to tell if you have it

  • Ra Medical Systems
  • DABRA Laser (RA-308 Excimer Laser)
  • Serial Numbers: RA00027 through RA00176

The hazard

The FDA said a software issue in the DABRA Laser system could result in user or patient injury or adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.

Context

GovInfoNow's records show Ra Medical Systems, Inc. has had five other recalls since Feb. 15, 2018. Other recent recalls include a DABRA Laser recall on Oct. 16, 2020, for footswitch liquid spill risk and a DABRA RA-308 Laser recall on July 24, 2020, for the risk of falling over. Similar product recalls include the Lutronic DermaV Laser System recall on Aug. 6, 2026, for patient burn risk and the Diowave Laser System recall on Jan. 9, 2026, for needed software updates.

How to tell if you have this one

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.

  • Brand
    Ra Medical Systems
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Number

    Look for the serial number on your DABRA Laser system to confirm if it falls within RA00027 to RA00176.

  2. Contact Manufacturer

    Reach out to Ra Medical Systems for guidance on next steps if your unit is affected.

Where it went and when

Where it was distributed

Distributed in 22 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: yesIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: yesORNevada: yesNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: yesKYWest Virginia: not listedWVVirginia: not listedVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: yesKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: yesLAMississippi: not listedMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “US: AL, AZ, CA, FL, GA, ID, IL, IN, KS, KY, LA, MI, MD, NC, NV, NY, OK, OR, PA, TN,TX, WI. OUS: Italy and Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Nevada, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Wisconsin.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Jan 23, 202012. FDA classified it Class II: Jul 4, 202023. Published in FDA’s Enforcement Report: Jul 15, 202034. FDA terminated the recall: Nov 1, 2021420202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-2497-2020 (January 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2497-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA