Ra Medical Systems Recalls DABRA Laser Units for Calibration Failure
Ra Medical Systems is recalling four DABRA Laser units because they failed to calibrate during setup. The devices were distributed in California and Pennsylvania.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ra Medical Systems Inc is recalling four units of the DABRA Laser (model RA-308). The device is a medical system designed to provide ultraviolet laser energy endovascularly through a catheter to cross occluded lesions in peripheral arteries. The recall is due to a defect where the lasers and catheters did not calibrate during the setup process prior to use.
The affected units have serial numbers 0016, 0039, 0044, and 0048. These devices were distributed in the United States, specifically in California and Pennsylvania. The DABRA Laser is a self-contained unit consisting of a light source and a single-use catheter, intended for use in peripheral artery procedures.
Consumers and healthcare providers who possess these specific serial numbers should stop using the devices and contact Ra Medical Systems Inc for further instructions on the recall.
The recalled product
- Product
- The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The…
- Manufacturer
- Ra Medical Systems Inc
- Category
- Medical Device — Laser Catheter
- Hazard
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Serial Numbers: 0016
- 0039
- 0044
- 0048
Distribution
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