MOBILEDIAGNOST WDR (2016-04-13)

Starting date:

April 13, 2016

Posting date:

May 16, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-58376

• Reason
• Affected products

Affected products 

1. MOBILEDIAGNOST WDR

Reason

Philips has become aware of the following issues:

1. The system may sporadically apply the default x-ray exposure parameters for an adult (patient type: "normal"), even though the patient type "newborn" was selected and is displayed in the generator control area of the Eleva user interface.
2. Under certain conditions, the detector might not be ready for examination. Released x-ray might lead to an image with artifacts and a retake is required. While the attachment process is running, the detector might be too short in front of the IR (infrared) sensor and the problem of the washed out images can appear if an exposure is taken right after that.

Affected products