Auriga 30 Laser System recall
Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Why was Auriga 30 Laser System recalled?
Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console.
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: 20413941, 20143944
- Product
- Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 2
- Distribution
- International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.
- Recall date
- March 14, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)