Recall of Device Recall Mobile Fluoroscopy System

Recall

49483

Class 2

Z-1709-2008

2008-07-02

2008-09-20

Terminated

United States

2009-01-20

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73590

Secondary collimator filters may be missing on certain x-ray units. it was discovered that the secondary collimator filter on some oec 9600 c-arms was omitted when a collimator assembly was replaced. this would reduce the filtration and therefore the half-value-layer (hvl) of the x-ray beam, and may result in non-compliance with respect to maximum entrance exposure rate (eer) unless the maximum ee.

Domestic customer notification letters were sent via certified mail on 07/02/2008. They were advised to have the Maximum EER assessed and to discontinue use if the maximum limits were exceeded.