Boston Scientific Recalls Two Auriga 30 Laser Systems for Assembly Defect
Boston Scientific is recalling two Auriga 30 Laser Systems because incorrectly assembled trigger wires may cause error codes or failure to start the console.
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 describes a functional defect (failure to start) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Boston Scientific Corporation is recalling two units of the Auriga 30 Laser System, Universal Part Number M0068S30G0. The affected devices are intended for use in surgical procedures and are identified by serial numbers 20413941 and 20143944.
The recall is due to incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console.
The affected units were distributed internationally to Australia, Vietnam, France, Germany, Italy, Spain, and Romania. Users should contact Boston Scientific Corporation for further instructions regarding the recall.
The recalled product
- Product
- Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Surgical Laser
- Hazard
- Affected units
- 2
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 (2)
- Serial Number: 20413941
- 20143944
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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