FDA-Device2025-10-08Class IIPROCESSING DEFECT
Philips Allura Xper FD10C medical imaging system recalled for BIOS battery depletion
What this means
The BIOS battery in some Philips Allura Xper FD10C X-ray systems may run out of power faster than expected. When this happens, the system will not start up, and there are no warning messages to alert users before the battery fails.
- If you operate an Allura Xper FD10C system, contact Philips Medical Systems immediately for guidance
- Do not attempt to restart the system repeatedly if it fails to start
- Follow Philips's instructions for battery replacement or service
The agency's original wording
Hazard
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.
Affected count
2 units (US only)
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Products
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2026Want us to check the next one for you?
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