Digital Diagnost (2018-09-25)

Starting date:

September 25, 2018

Posting date:

October 5, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67900

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  Reason
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  Affected products

Affected products

Digital Diagnost

Reason

Philips has become aware of the following issues:

Issue #1: Stitching run on SkyPlate detector interrupted intermittently: when stitching image acquisition by means of the SkyPlate detector, the system software is designed such that

the expected interval between two consecutive images is not smaller than eight seconds. If the detector readout time is faster so that the next image could be read in a time interval shorter than eight seconds, the synchronization between the detector and the system software results in a system abort of the stitching run. If this occurs, the stitching run needs to be repeated from the beginning.

Issue #2: Stitching with SkyPlate aborts after first image: if there is an improper synchronization between the SkyPlate detector and the system, the preview offset image will have artifacts. If this happens, the system software identifies the preview image buffer as not usable during the first part image acquisition of the stitching run and as a result will abort the run.

The stitching run has to be repeated.

Issue #3: System Software CD contains wrong baseline: DigitalDiagnost systems with system software versions 4.1.8 and 4.2.5 were delivered with a wrong system application software version on the cd. This wrong application software contains an error resulting in a failure that the mirrored image is not indicated as a mirrored image.

Affected products