Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Reported: March 14, 2018 Initiated: September 22, 2017 #Z-0897-2018
Product Description
Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Reason for Recall
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 2
- Distribution
- International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.. Recalled by Boston Scientific Corporation. Units affected: 2.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 14, 2018. Severity: Moderate. Recall number: Z-0897-2018.
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