Philips Allura Xper Medical Imaging Systems Recalled for Startup Failure

What You Should Do

1. This recall involves various Philips Allura Xper and Allura Centron cardiovascular imaging systems used in hospitals and surgical centers, including FD10, FD20, and CV20 models.
2. Hospital engineering and clinical staff should identify if their imaging systems are affected by checking the system model and serial numbers. See the Affected Products section below for the full list of affected codes.
3. Stop using the recalled device if it fails to start up or turn on as expected.
4. Contact Philips Medical Systems Nederland B.V. or your local Philips service representative immediately to arrange for a system correction or battery replacement.
5. Laboratory supervisors and clinical staff should report any startup failures or related incidents to the manufacturer and their local regulatory authority.
6. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Your Remedy Options

Affected Products