DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
FDA Recall Z-0569-2021 · Posted None
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Recalling FirmRa Medical Systems, Inc.
Recall StatusTerminated
Product CodePDU
Date Initiated2020-10-16
Date Terminated2023-01-11
Product Quantity36 devices
Reason for Recall
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.
Firm Action
On 10/29/2020, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification via certified mail informing them of the potential for the footswitch to fail to operate properly if liquid is spilled near or on the footswitch. On 11/16/2020, the firm sent out an updated customer notification. The firm is instructing customers to discontinue using the footswitch if liquids have been spilled on or splashed on the floor near or on the footswitch. The Recalling Firm will ship a replacement footswitch and will provide shipping materials for users to return the old footswitch. Instructions will be provided on how to install the new footswitch and return the old footswitch.
Customers are asked to fill out and return the Acknowledgement and Receipt Form via FAX to 760-867-2706 or email at [email protected].
For any questions, contact the Recalling Firm at: 1-877-635-1800 Monday thru Friday 8:00 a.m. to 5:00 p.m. PST
Root Cause
Device Design
Distribution Pattern
US Distribution to states of: AL, AZ, CA, FL, IL, IN, KY, LA, MD, NC, NV, NY, OK, OR, TX, and WA; and to OUS country: Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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