Ra Medical Systems recalls DABRA RA-308 Excimer Laser units with footswitch that may fail if liquids spill, risking unintended laser activation during vascular procedures.
Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase.
Ra Medical Systems is recalling DABRA Laser (RA-308 Excimer Laser) units because the footswitch may fail if liquids spill near it, potentially causing the laser to activate unexpectedly during medical procedures. This could lead to unintended tissue damage if the laser operates without proper control.
The footswitch is designed to prevent liquid or solid ingress, but if liquids spill near it, the device may activate unexpectedly. This could cause unintended laser operation during vascular treatments, potentially damaging tissue.
Medical professionals using the DABRA Laser for vascular procedures are most at risk. Patients undergoing these procedures may be affected if the device malfunctions during treatment.
Check for serial numbers listed: RA00027, RA00046, RA00049, RA00050, RA00054, RA00056, RA00057, RA00058, RA00064, RA00069, RA00073, RA00081, RA00083, RA00084, RA00085, RA00089, RA00097, RA00098, RA00114, RA00115, RA00120, RA00121, RA00125, RA00127, RA00135, RA00138, RA00148, RA00153, RA00154, RA00160, RA00164, RA00165, RA00167, RA00170, RA00175, and RA00177.
Inspect the footswitch for signs of liquid exposure or damage, as this could cause the laser to activate unexpectedly.
The footswitch may fail if liquids spill near it, potentially causing the laser to activate unexpectedly during vascular procedures.
The affected units have serial numbers: RA00027, RA00046, RA00049, RA00050, RA00054, RA00056, RA00057, RA00058, RA00064, RA00069, RA00073, RA00081, RA00083, RA00084, RA00085, RA00089, RA00097, RA00098, RA00114, RA00115, RA00120, RA00121, RA00125, RA00127, RA00135, RA00138, RA00148, RA00153, RA00154, RA00160, RA00164, RA00165, RA00167, RA00170, RA00175, and RA00177.
The recall record does not specify a remedy or fix for this issue.
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-0569-2021 — Ra Medical Systems Ra Medical Systems Hello, I own a Ra Medical Systems that is covered by recall Z-0569-2021 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.
