Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation
Boston Scientific is recalling two Auriga 30 laser systems because a mechanical cooling issue may cause faster-than-normal power degradation and a low power error.
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 mechanical defect leading to power degradation, but the device is designed to stop emitting laser pulses and enter stand-by mode, mitigating the risk of injury. No injuries or illnesses are reported.
Plain-English summary
Boston Scientific Corporation is recalling two units of the Auriga 30 General Zero Cost System (UPN: M0068S30GZ0). The affected serial numbers are 21302836 and 21302929. These devices were distributed worldwide to 24 countries, including the United States, Australia, and Germany.
The recall is due to a potential issue in the mechanical cooling system that may cause the consoles to exhibit faster than normal power degradation. This issue can 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 error message is displayed.
Healthcare providers should stop using the affected units and contact Boston Scientific for further instructions. The devices are intended for use in various surgical procedures, including urology, gastroenterology, and general surgery.
The recalled product
- Product
- AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 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…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Surgical Laser
- 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: 21302836
- 21302929
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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