AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 recall: Impurity Out of Spec
AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic…
Why was AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Number: 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
- Product
- AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 27 (OUS)
- Distribution
- Worldwide distribution to 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
- Recall date
- May 29, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)