Mobilediagnost WDR (2014-01-10)

Starting date:

January 10, 2014

Posting date:

April 30, 2014

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-39251

• Reason
• Affected products

Recalled Products

Mobilediagnost WDR

Reason

Philips has become aware that under very specific error conditions the system may execute an unintended exposure:

• the hand switch is erroneously stuck in pressed position, while the system is switched off,
• the system is powered up with the hand switch in that erroneous condition,
• the user logs in, selects a patient for examination, gets a green ready light in the examination context, if the tube arm is then moved out of the zero position, the system is doing an exposure.

Affected products