Ra Medical Systems recalls DABRA Laser (model RA-308) due to potential laser calibration errors during setup, which could affect medical procedures. Affected units have specific serial numbers.
Lasers/Catheters did not calibrate during set-up prior to use.
Ra Medical Systems is recalling the DABRA Laser (model RA-308) because it may not calibrate correctly during setup. This could lead to improper laser energy delivery during medical procedures, potentially causing harm to patients.
The laser system may not calibrate properly during setup, which could result in incorrect energy delivery to target areas. This might cause ineffective treatment or unintended damage to blood vessels during procedures.
Medical professionals using the DABRA Laser for vascular procedures are likely affected. Patients undergoing treatments with this device may be at risk if the calibration issue occurs.
Check for the model RA-308 with serial numbers 0016, 0039, 0044, or 0048. The device is used for medical procedures involving vascular treatments.
Verify the serial number on the device to confirm if it is one of the affected units: 0016, 0039, 0044, or 0048.
The DABRA Laser is designed to provide ultraviolet laser energy endovascularly through a catheter to treat occluded lesions in peripheral arteries.
The affected serial numbers are 0016, 0039, 0044, and 0048.
The recall record does not specify a remedy.
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-2218-2019 — Ra Medical Systems Ra Medical Systems Hello, I own a Ra Medical Systems that is covered by recall Z-2218-2019 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.
