Philips Easydiagnost Eleva

• • Ongoing Z-0279-2024 FDA Class II ·initiated 21 Sep 2023 ·on shared 510(k) K031535

  Potential for units suspended on the ceiling to fail and fall.

• • Terminated Z-2523-2020 FDA Class II ·initiated 2 Jun 2020 ·on shared 510(k) K031535

  Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.

• • Terminated Z-0311-2018 FDA Class II ·initiated 14 Jul 2017

  If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. This may happen when the detector is rotated clockwise from landscape to portrait position.

• • Terminated Z-0365-2016 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-0431-2014 FDA Class II ·initiated 30 Oct 2013

  The delivered application software was an outdated version to the model of equipment.

• • Terminated Z-0767-2013 FDA Class II ·initiated 16 Jan 2013

  The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.

• • Terminated Z-2208-2012 FDA Class II ·initiated 11 Jul 2012 ·on shared 510(k) K031535

  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 ·on shared 510(k) K031535

  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-1283-2012 FDA Not yet classified ·initiated 9 Mar 2012 ·on shared 510(k) K031535

  Underexposed image due to lag in switching between auxiliaries

• • Terminated Z-1216-2012 FDA Not yet classified ·initiated 14 Feb 2012

  Misinterpretation of Mirror Icon-Mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system

• • Terminated Z-0916-2011 FDA Unclassified (pre-2012) ·initiated 6 Mar 2009 ·on shared 510(k) K031535

  Images from two different patients may be combined in one patient folder in the Digital Image (DI) or may be combined as one (printed) image. It is possible that an image of a previous patient registered in the DI will be overwritten with an image of a later patient.

• • Terminated Z-0479-2011 FDA Unclassified (pre-2012) ·initiated 21 Jan 2009

  Patient and image data can be exchanged when a patient is selected in the patient list and the examination tab is pressed with background query running at the same time. There is a risk that the data may then be linked to the incorrect patient, which may adversely affect diagnosis and treatment.

• • Terminated Z-0353-2009 FDA Unclassified (pre-2012) ·initiated 10 Dec 2008 ·on shared 510(k) K031535

  Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.

• • Terminated Z-2194-2010 FDA Unclassified (pre-2012) ·initiated 9 Jul 2008

  Potential for bright artifacts to appear on the patient image from a previous exposure.

• • Terminated Z-0910-2007 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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K031535 ↗

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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