Boston Scientific recalls AURIGA XL 4007 Brazil System model M0068FS4007B0 due to potential power degradation causing low power errors in surgical laser systems.
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
Boston Scientific is recalling certain AURIGA XL 4007 Brazil System laser consoles because they may show a low power error (1301) due to a cooling system issue. This could cause the device to stop emitting laser pulses during surgery, potentially affecting procedures.
The console may degrade power faster than normal because of a problem in its cooling system. This can trigger a low power error message (1301), causing the device to stop emitting laser pulses temporarily during surgery.
Surgical staff using the AURIGA XL 4007 Brazil System model M0068FS4007B0 for procedures like urology, gynecology, or general surgery are most at risk. The device is used in hospitals and clinics by medical professionals.
Check for the model number M0068FS4007B0 on the device label. The product was sold as the AURIGA XL 4007 Laser System and Auriga 30 Laser System with a fiber optic delivery system for surgical procedures.
Look for error code 1301 on the console screen, which indicates the device may have stopped emitting laser pulses due to power issues.
The recall is due to a potential issue in the mechanical cooling system that may cause faster power degradation and a low power error (1301) message.
The console will stop emitting laser pulses and enter stand-by mode. Continue using the device but monitor for further errors.
The device is designed to stop emitting laser pulses when a low power error occurs, but the recall indicates a potential risk of power degradation that could affect surgery.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1391-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1391-2019 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
