FDA Devices recall · Reported July 15, 2020
DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The optical conduit is used in conjunction with existing endovascular accessories and tools to complete a surgical procedure. The software is programmed onto an EEPROM chip, which is a component of the DABRA Excimer Laser RA-308 s
A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (…
Ra Medical Systems, Inc. recalled DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer lase… - a moderate-severity action.
DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer lase… was recalled by Ra Medical Systems, Inc. in July 15, 2020. Reason: A software issue was identified which could result in user or patient injury, or may adversely impact laser p…. Check the official notice for the remedy. Verify recall #Z-2497-2020 with the FDA Devices before acting.
The recall
Ra Medical Systems, Inc. issued this moderate-severity FDA Devices recall-A software issue was identified which could result in user or patient injury, or may adversely impact laser p….
- Moderate
- severity level
- 79 units
- affected scope
- Class II
- classification
- July 15, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2497-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The optical conduit is used in conjunction with existing endovascular accessories and tools to complete a surgical procedure. The software is programmed onto an EEPROM chip, which is a component of the DABRA Excimer Laser RA-308 system. Catheter for crossing total occlusions in vascular system.
Reason for recall
A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2497-2020 |
| Date reported | July 15, 2020 |
| Date initiated | January 23, 2020 |
| Recalling firm | Ra Medical Systems, Inc. |
| Firm location | Carlsbad, CA |
| Affected scope | 79 units |
| Distribution | US: AL, AZ, CA, FL, GA, ID, IL, IN, KS, KY, LA, MI, MD, NC, NV, NY, OK, OR, PA, TN,TX, WI. OUS: Italy and 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-2497-2020) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026