Philips Bucky Diagnost Family

• • Terminated Z-1806-2020 FDA Class II ·initiated 7 Apr 2020

  If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.

• • Terminated Z-0766-2016 FDA Class II ·initiated 22 Jul 2015

  If arm is not fastened securely it could fall down.

• • Terminated Z-0364-2016 FDA Class II ·initiated 19 Aug 2014

  The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.

• • Terminated Z-1450-2013 FDA Class II ·initiated 16 Jan 2013

  An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) records shows table height measurements out of specification with the consequence of potential system mis-alignment

• • Terminated Z-1449-2013 FDA Class II ·initiated 16 Jan 2013

  An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used

• • Terminated Z-0021-2011 FDA Unclassified (pre-2012) ·initiated 9 Sep 2010

  Potential of broken strands in the main steel cable supporting the accessory holder used with BuckyDiagnost and DigitalDiagnost X-ray systems.

• • Terminated Z-0848-2010 FDA Unclassified (pre-2012) ·initiated 21 Jan 2010

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

• • Terminated Z-0907-2007 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.

• • Terminated Z-1084-05 FDA Unclassified (pre-2012) ·initiated 24 Feb 2005

  Systems do not comply with the labeling performance standards.

• • Terminated Z-0268-04 FDA Unclassified (pre-2012) ·initiated 18 Nov 2003

  Support chain attachment on the Bucky carriage may fail and cause the counter weights or X-ray tube to fall.

510(k) Number

K945278 ↗

FDA Product Code

KPR

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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