Boston Scientific recalls AURIGA XL 4007 Laser Systems with serial numbers 21303005-21303090 due to potential power degradation causing low power errors. Patients may need to stop using the device after an error message appears.
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 specific models of AURIGA XL 4007 Laser Systems because a cooling issue might cause the device to show a low power error message. This could stop the laser from working during surgery. Affected units have serial numbers starting with 21303005.
The device's mechanical cooling system might degrade faster than normal, causing it to display a low power error message. When this happens, the laser stops emitting pulses and goes into a stand-by mode, which could interrupt surgery.
Medical professionals using the AURIGA XL 4007 Laser System for surgical procedures are most at risk. Patients undergoing surgery with these systems may need to stop using the device if a low power error appears.
Check for serial numbers 21303005, 21303006, 21303043, 21303089, 21303066, or 21303090 on the device. The product is used in surgical procedures like laparoscopy and endoscopy.
If the device displays a low power error message (1301), stop using it immediately and contact Boston Scientific.
The recalled product is the AURIGA XL 4007 Laser System with serial numbers 21303005, 21303006, 21303043, 21303089, 21303066, and 21303090.
The device may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system, which can cause a low power error message.
Stop using the device immediately and 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-1394-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1394-2019 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.
