Boston Scientific recalls AURIGA 30 laser systems with 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 30 laser systems due to a potential issue in the cooling system that could cause the device to display a low power error message. This might stop the laser from emitting pulses during surgery, which could affect medical procedures.
The device may show a low power error message due to faster than normal power degradation from a cooling system issue. When this happens, the console stops emitting laser pulses and enters a stand-by mode, potentially interrupting surgery.
Surgical staff using the AURIGA 30 laser system for procedures like urology, gynecology, and general surgery are most at risk. Patients undergoing these procedures may be affected if the system malfunctions.
Check for the serial numbers 21302966, 21303016, or 21303021 on the AURIGA 30 laser system. The product includes a fiber optic delivery system for surgical procedures.
Look for a low power error message (1301) on the console screen indicating potential power degradation.
Reach out to Boston Scientific for specific remedy instructions as the recall record does not provide a remedy.
The system may display a low power error message (1301) due to faster than normal power degradation from a cooling system issue, causing the console to stop emitting laser pulses.
Serial numbers 21302966, 21303016, and 21303021 are affected.
Contact Boston Scientific directly for remedy instructions as the recall record does not specify a remedy.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1396-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1396-2019 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.
