Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 23, 2020
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.
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' p…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ra Medical Systems, Inc. recalled DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occl… - a moderate-severity action.
DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occl… was recalled by Ra Medical Systems, Inc. in December 23, 2020. Reason: Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If sp…. Check the official notice for the remedy. Verify recall #Z-0569-2021 with the FDA Devices before acting.
The recall
Ra Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If sp….
- Moderate
- severity level
- 36 units
- affected scope
- Class II
- classification
- December 23, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0569-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0569-2021) was formally reported on December 23, 2020, with the manufacturer initiating the action on October 16, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Ra Medical Systems, Inc. is listed as the recalling firm, operating out of Carlsbad, CA. Federal records list the affected scope as 36 devices.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
36 devices
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0569-2021 |
| Date reported | December 23, 2020 |
| Date initiated | October 16, 2020 |
| Recalling firm | Ra Medical Systems, Inc. |
| Firm location | Carlsbad, CA |
| Affected scope | 36 devices |
| Distribution | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0569-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ra Medical Systems, Inc.. Units affected: 36 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 23, 2020. Severity: Moderate. Recall number: Z-0569-2021.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0569-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 23, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.