Boston Scientific recalls certain Auriga XL 4007 laser systems due to potential power degradation causing low power errors. Affected units may stop emitting laser pulses during surgery. Contact for remedy details.
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 specific models of Auriga XL 4007 laser systems that may show a low power error message due to a cooling system issue. This could cause the system to stop emitting laser pulses during surgery, potentially affecting medical procedures.
The console may degrade power faster than normal because of a potential issue in the mechanical cooling system. This can trigger a low power error message (1301) on the screen, causing the system to stop emitting laser pulses and enter stand-by mode during surgery.
Medical professionals using the Auriga XL 4007 laser system for surgical procedures are most at risk. The recall affects specific serial numbers used in hospitals and clinics.
Check for the serial numbers 21302939, 21302937, and 21302938 on the Auriga XL 4007 Laser System or Auriga 30 Laser System. These units were sold as demo systems with the specific product code M0068FS4007GD0.
Look for error message 1301 on the console screen indicating low power degradation.
The recall is due to a potential issue in the mechanical cooling system that may cause faster power degradation, leading to a low power error message (1301) on the console screen.
The console will stop emitting laser pulses and enter stand-by mode. Contact Boston Scientific for further instructions.
Yes, the affected serial numbers are 21302939, 21302937, and 21302938.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1393-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1393-2019 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.
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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.
