Boston Scientific recalls specific 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 certain Auriga XL 4007 laser systems that may experience faster power degradation, leading to low power error messages. This could cause the system to stop emitting laser pulses during surgical procedures. Affected units are identified by specific serial numbers.
The mechanical cooling system in certain Auriga consoles may degrade faster than normal, triggering a low power error message. When this occurs, the console stops emitting laser pulses and enters stand-by mode, potentially interrupting surgery.
Medical professionals using the Auriga XL 4007 laser system for surgical procedures are most at risk. Patients undergoing surgery with these systems may experience interrupted treatments.
Check for serial numbers listed: 21302771, 21302815, 21302786, 21302800, 21302843, 21302928, 21302842, 21302915, 21302900, 21302933, 21302783, 21302922, 21302934, 21302935, 21302942, 21302956, 21302957, 21302989, 21303002, 21303000, 21303001, 21303067, 21303004, 21303044, 21303042, 21302899, 21303091.
Verify if your device has a serial number from the list provided in the recall notice.
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system, which can lead to a low power error message.
The console stops emitting laser pulses and enters stand-by mode after a low power error message, potentially interrupting surgical procedures.
The recall notice does not specify a remedy, so contact Boston Scientific directly 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-1392-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1392-2019 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.
