Boston Scientific recalls AURIGA 30 laser systems due to potential power degradation causing low power errors. Affected units may stop emitting laser pulses during surgery. Contact for repair or replacement.
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 AURIGA 30 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 procedures.
The laser console may degrade power faster than normal because of a problem in its cooling system. This can cause the system to display a low power error message and stop emitting laser pulses during surgery, which could disrupt procedures.
Surgical staff using the AURIGA 30 laser system for procedures like urology, gynecology, or general surgery are most at risk. Patients undergoing these procedures may be affected if the system stops emitting laser pulses unexpectedly.
The AURIGA 30 General Zero Cost System with serial numbers 21302836 and 21302929 is affected. This system is used in surgical procedures such as urology, gynecology, and general surgery.
Look for a low power error message (1301) on the console screen during use.
The recall is due to a potential issue in the mechanical cooling system that may cause faster power degradation and a low power error message.
The console will stop emitting laser pulses and enter stand-by mode. Contact Boston Scientific for repair or replacement.
Yes, the AURIGA 30 General Zero Cost System with serial numbers 21302836 and 21302929 is affected.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1399-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1399-2019 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.
