Boston Scientific recalls specific AURIGA 30 Laser Systems that may display low power error (1301) due to mechanical cooling problems. Affected units may stop emitting laser pulses and enter standby mode. Contact for 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 certain AURIGA 30 Laser Systems that may show a low power error message (1301) because of a potential issue in the cooling system. This could cause the system to stop emitting laser pulses and enter standby mode during surgery.
The console may experience faster than normal power degradation due to a mechanical cooling system issue. This can trigger a low power error message (1301) on the screen, causing the system to stop emitting laser pulses and enter standby mode.
Medical professionals using the AURIGA 30 Laser System for surgical procedures are likely affected. The risk is low as the system automatically stops emitting laser pulses when the error occurs.
Check for the serial numbers listed: 21302793, 21302835, 21302799, 21302844, 21302861, 21302780, 21302921, 21302999, 21303007, 21303013, 21303012, 21303064, 21303032, 21303033, 21303045, 21303065, 21302816, 21302994.
Look for a low power error message (1301) on the console screen during operation.
The recalled models are the Auriga XL 4007 Laser System and Auriga 30 Laser System with the specific serial numbers listed in the recall notice.
The recall is due to a potential issue in the mechanical cooling system that may cause faster than normal power degradation, leading to a low power error message (1301).
The system will automatically stop emitting laser pulses and enter standby mode. Contact Boston Scientific for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1397-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1397-2019 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.