Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation
Boston Scientific is recalling specific Auriga 30 laser systems because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.
What this means for you
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 defect (power degradation) that triggers a safety shutdown, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Boston Scientific Corporation is recalling specific units of the Auriga 30 Brazil Zero Cost System (UPN: M0068S30BZ0). The affected devices are surgical laser systems intended for use in various medical specialties, including urology, gastroenterology, and general surgery. The recall involves three units with serial numbers 21302966, 21303016, and 21303021.
The recall is being conducted because certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system. This defect could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enter a stand-by mode after this low power error message is displayed.
The affected units were distributed worldwide to numerous countries, including Australia, Belgium, Brazil, Chile, Colombia, Egypt, France, Germany, Great Britain, India, Indonesia, Iran, Italy, Lebanon, Malaysia, Mexico, Romania, Russia Fed., South Africa, South Korea, Spain, Taiwan, United Arab Emirates, and Vietnam. Healthcare providers and facilities that have these specific serial numbers should contact Boston Scientific for further instructions.
The recalled product
- Product
- AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform inc
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 3
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 (3)
- Serial Number: 21302966
- 21303016
- 21303021
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 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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