FDA (Devices) recall action 79096
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Boston Scientific is recalling nine Auriga XL 4007 Laser Systems because incorrectly assembled trigger wire components may cause error codes or prevent the consoles from starting.
Boston Scientific is recalling two Auriga 30 Laser Systems because incorrectly assembled trigger wires may cause error codes or failure to start the console.