Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation
Boston Scientific is recalling eight Auriga 30 laser systems worldwide because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could impact surgical procedures, but the device has a built-in safety mechanism that stops laser emission, and no injuries or illnesses are reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling eight units of the Auriga 30 Brazil System (UPN: M0068S30B0) due to a potential issue in the mechanical cooling system. The affected devices are intended for use in various surgical procedures, including urology, gastroenterology, and general surgery.
The recall is being conducted because certain Auriga consoles may exhibit faster than normal power degradation. This issue can lead to a low power error (1301) being displayed on the screen. When this error occurs, the console is designed to stop emitting laser pulses and enter a stand-by mode.
The affected units were distributed worldwide to countries including Australia, Belgium, Brazil, Chile, Colombia, Egypt, France, Germany, Great Britain, India, Indonesia, Iran, Italy, Lebanon, Malaysia, Mexico, Romania, Russia Fed., South Africa, South Korea, Spain, Taiwan, United Arab Emirates, and Vietnam. Users should identify their specific serial numbers against the list provided in the official recall notice to determine if their device is affected.
The recalled product
- Product
- AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, exci
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Surgical Laser
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Serial Number: 21302772
- 21302803
- 21302784
- 21302930
- 21302967
- 21302968
- 21302985
- 21303026
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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