Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1394-2019·Announced 2019-05-29

Boston Scientific Recalls Auriga XL 4007 Laser Systems for Cooling Defect

Boston Scientific is recalling six Auriga XL 4007 laser systems worldwide due to a mechanical cooling issue that may cause power degradation and stop laser emission.

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, and the source text describes a functional failure (power degradation) that results in the device entering a safe stand-by mode without reporting any injuries or illnesses.

Plain-English summary

Boston Scientific Corporation is recalling six units of the Auriga XL 4007 General - Zero Cost System (UPN: FS4007GZ0). The affected devices are intended for use in various surgical procedures, including urology, gastroenterology, and general surgery, to perform incision, excision, and coagulation of soft tissue.

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 defect can lead to a low power error (1301) being displayed on the screen. When this error occurs, the console is designed to stop emitting laser pulses and enter a stand-by mode.

The affected units were distributed worldwide to 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. The specific serial numbers for the recalled units are 21303005, 21303006, 21303043, 21303089, 21303066, and 21303090.

The recalled product

Product: AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 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 — Surgical Laser
Hazard: functional-failure
power-degradation
Affected units: 6

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 (6)

Serial Number: 21303005
21303006
21303043
21303089
21303066
21303090

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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