Boston Scientific Recalls Auriga XL 4007 Laser Systems Due to Assembly Defect
Boston Scientific is recalling nine Auriga XL 4007 Laser Systems because incorrectly assembled trigger wire components may cause error codes or prevent the consoles from starting.
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. The hazard involves a functional failure (failure to start) rather than a direct risk of serious injury or death, and no illnesses or injuries are reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling nine units of the Auriga XL 4007 Laser System, Universal Part Number M0068FS4007G0. These devices are intended for use in surgical procedures. The recall involves specific serial numbers: 20509715, 20465096, 20503137, 20520960, 20541967, 20546219, 20546440, 20575512, and 20575518.
The recall is being issued because certain Auriga consoles have 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. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these devices.
The recalled product
- Product
- Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Surgical Laser
- Affected units
- 9
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 (9)
- Serial Number: 20509715
- 20465096
- 20503137
- 20520960
- 20541967
- 20546219
- 20546440
- 20575512
- and 20575518.
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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