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FDA-Device2024-12-18Class II

Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Hazard

Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and possible need to expose the patient to additional unnecessary radiation during re-examination.

Sold states
Nationwide distribution. International distribution to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Oman, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen.
Affected count
2,782 units
Manufactured in
Veenpluis 4-6, Best, Netherlands
Products
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0676-2025

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