Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Philips Allura Xper FD10/10

25 Jun 2013

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device alert concerning Allura Xper FD10/10, which is a biplane cardiovascular X-ray system manufactured by Philips. All systems are affected.

The medical device alert mentions that the table will reboot if users attempt a powered and manual movement at the same time. The reboot will take approximately 90 seconds during which time no motorised movement will be possible. This has led to delay during emergency treatment. Basic imaging will still be available.

The MHRA reminds the superintendent diagnostic radiographers to identify the affected devices and inform users of the issue.

For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON286972

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

Posted on 25 June 2013

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