Philips Easy Diagnost

• • Terminated Z-2208-2012 FDA Class II ·initiated 11 Jul 2012

  Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors.

• • Terminated Z-1821-2012 FDA Class II ·initiated 11 May 2012

  If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. As a result of this, a surgical intervention may be execut

• • Terminated Z-0849-2010 FDA Unclassified (pre-2012) ·initiated 21 Jan 2010

  Device failed to display appropriate labels indicating Radiation Symbol along with the required wording.

• • Terminated Z-2405-2010 FDA Unclassified (pre-2012) ·initiated 4 Jan 2008

  Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and potentially injure a patient or user in its path.

• • Terminated Z-0909-2007 FDA Unclassified (pre-2012) ·initiated 23 Jul 2007

  Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures.

510(k) Number

K970640 ↗

FDA Product Code

IXR

Device Class

Class II

Regulation

21 CFR Part 892.1980

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• Orthoralix Sd/Orthoralix Sd Ceph

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• Doppler Option for Platinum

  Class II

  FDA 510(k) K900002 Active Cleared 2 Apr 1990

• Philips Bucky Diagnost Family

  Class II

  FDA 510(k) K945278 Active Cleared 14 Dec 1994

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