Boston Scientific Recalls Auriga XL 4007 Laser Systems for Cooling Defect
Boston Scientific is recalling 27 Auriga XL 4007 laser systems worldwide due to a mechanical cooling issue that may cause the device to stop emitting laser pulses during surgery.
What this means for you
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 involves a medical device used in surgical procedures where a failure to emit laser pulses could interrupt a procedure, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 27 units of the Auriga XL 4007 General System, identified by UPN M0068FS4007G0. These laser systems are intended for use in various surgical procedures, including open, laparoscopic, and endoscopic surgeries, to perform incision, excision, and other soft tissue treatments across multiple medical specialties.
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 24 countries, including the United States, Australia, Brazil, Germany, and India. Specific serial numbers for the recalled units are listed in the official recall documentation. Healthcare facilities and users should stop using the affected units and contact Boston Scientific for further instructions.
The recalled product
- Product
- AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 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 incis
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Surgical Laser
- Affected units
- 27
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 (20)
- Serial Number: 21302771
- 21302815
- 21302786
- 21302800
- 21302843
- 21302928
- 21302842
- 21302915
- 21302900
- 21302933
- 21302783
- 21302922
- 21302934
- 21302935
- 21302942
- 21302956
- 21302957
- 21302989
- 21303002
- 21303000
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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