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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86692

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 16, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ra Medical Systems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0569-2021
Recall number
Z-0569-2021
Initiated
October 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Ra Medical Systems, Inc.
Quantity
36 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

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.

Code information

Model Number RA-308 Product/Catalog Number: 1200-0001-01 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.

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.

Field note

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