Medical device manufacturer, Philips, has issued a medical device safety alert concerning its Azurion System with software version 1.2.

The manufacturer has identified the following issues:

Issue 1 – System Cold Restart Time May Be Prolonged

• The cold restart of affected product may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days.

Issue 2 – Poor Image Quality

• When performing Cine runs, its automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.
• The problem may occur after the following sequence of events:
  1. Thickness of the patient is 30 cm or more.
  2. A fluoro scan is performed.
  3. A field of view (FOV) different than the largest FOV is selected.
  4. A cine run is performed.
• The problem does not occur: if the largest FOV is selected or when performing Fluoroscopy or Test Shot Lock In (TSLI) runs.

According to the manufacturer, the software version of the affected product is shown on the start-up screen:

• If the start-up screen shows software version R1.2, the system has the affected release and FCO72200430 should be implemented on the system.
• If the start-up screen shows software version R1.2.1, the system has the latest system software release and is not affected by the issues.

For the Issue 1, a prolonged cold restart time may result in a delay of treatment. If the delay occurs during a critical moment of the procedure, there is a potential for harm for the patient.

For the Issue 2, if the quality of the images obtained during the Cine run is inadequate for diagnostic purposes, the study may have to be repeated, requiring additional x-ray radiation of the patient, the administration of additional contrast agent to the patient, and a prolonged procedure time.

The manufacturer has modified the system software to correct the problem. The updated software (release R1.2.1) will be installed in all affected systems (reference FCO72200430). The affected customers are advised to include the Field Safety Notices with the documentation of the system until the manufacture implements the correction in the system.

For the Issue 1, the customers are also advised to take the following action:

• At least once every 50 days, briefly disconnect the affected product from the mains power supply. Be aware that when an Uninterruptible Power Supply is installed, the room emergency power off switch should be used to interrupt the mains power supply to the system. Note that this might also shut down other devices or equipment in the room.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 15 July 2019