Agency classClass IIOur severity:High FDA (Devices)·Z-1393-2019·Announced 2019-05-29

Boston Scientific Recalls Auriga XL 4007 Laser Systems Due to Power Degradation

Boston Scientific is recalling three Auriga XL 4007 laser systems because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) as it involves a risk of harm where the probability of serious adverse health consequences is remote, and no specific injuries or illnesses are reported in the source text.

Plain-English summary

Boston Scientific Corporation is recalling three Auriga XL 4007 General Demo Systems. 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 could lead to a low power error (1301) being displayed on the screen.

The affected consoles are designed to stop emitting laser pulses and enter a stand-by mode after a low power error message is displayed. The recall covers three units with serial numbers 21302939, 21302937, and 21302938. These units were distributed worldwide to various countries including Australia, Belgium, Brazil, and the United States.

The FDA has classified this recall as Class II, meaning the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Users should contact Boston Scientific for further instructions on how to proceed with the recall.

The recalled product

Product: AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 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…
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Laser Systems
Hazard: power-degradation
cooling-failure
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: 21302939
21302937
21302938

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.

See all 9 products in this recall →

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Same hazard · power degradation