DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
FDA Recall Z-0050-2021 · Posted None
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Recalling FirmRa Medical Systems, Inc.
Recall StatusTerminated
Product CodePDU
Date Initiated2020-07-24
Date Terminated2023-08-09
Product Quantity54 units
Reason for Recall
Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
Firm Action
On August 10, 2020, the firm sent an "Urgent Medical Correction" letter to customers, informing them of the incorrect laser wheel size, which upon moving or adjusting the laser with the wheels in locked position may fall over. If this were to happen during a medical procedure, user or patient injury may occur.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, ID, IL, IN, KS, KY, LA, MA, MD, MI, NC, NV, NY, OR, OK, PA, TX, WA and the country of 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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