Boston Scientific recalls AURIGA 30 Laser Systems with specific serial numbers due to potential power degradation causing low power errors. Affected units may stop emitting laser pulses during surgery.
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 due to a cooling system issue. This could cause the system to stop emitting laser pulses during surgical procedures.
The laser console may degrade power faster than normal because of a potential issue in the mechanical cooling system. This can cause the system to display a low power error (1301) and stop emitting laser pulses during surgery.
Surgical professionals using the AURIGA 30 Laser System for procedures like urology, gynecology, and general surgery. Patients undergoing these procedures with affected units are at risk.
Check for serial numbers: 21302772, 21302803, 21302784, 21302930, 21302967, 21302968, 21302985, 21303026. The product is the AURIGA 30 Laser System used in surgical procedures.
Verify your unit's serial number against the list: 21302772, 21302803, 21302784, 21302930, 21302967, 21302968, 21302985, 21303026.
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system, which can cause a low power error (1301) message and stop emitting laser pulses.
Check your serial number against the list: 21302772, 21302803, 21302784, 21302930, 21302967, 21302968, 21302985, 21303026.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1395-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1395-2019 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.
