Device Recall Ellex Motorised Safety Filter 의 리콜

Recall

54019

Class 2

Z-0578-2010

2009-02-11

2010-01-20

Terminated

United States

2012-09-07

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87210

Potential for two screws important in the design of the safety filter to come loose.

Ellex issued a bulletin stating the problem and identifying the affected products. Customers are to remove the Motorised Safety Filter from clinical use if the green laser light is visible while viewing through the microscope at any time during use of the Solitaire laser. The Bulletin also states that customers should contact an Ellex approved Service Engineer to investigate and perform the Field Corrective Action listed. The manufacturer will remedy the defect or bring the product into compliance free of charge. Ellex will inspect and rework all affected safety filters sold prior to February 2009.