Philips Medical Systems Nederland B.V. recalled 5,067 Allura Xper FD20 devices on September 3, 2025. The BIOS battery may deplete unexpectedly, halting the system's start-up process. This issue affects models 722006, 722012, and 722028 and poses a high risk to patient safety.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: Letter
The recalled models are Allura Xper FD20 with model numbers 722006, 722012, and 722028. These devices were distributed worldwide, including the U.S. and multiple countries. The quantity recalled is 5,067 units.
The BIOS battery in these devices may deplete faster than expected. When the battery is depleted, the system fails to start, presenting a risk to patient care.
No specific incidents have been reported, but the potential for system failure without prior warning poses a significant risk.
Patients and healthcare providers should immediately stop using the affected devices. Contact Philips Medical Systems or your healthcare provider for further instructions.
For more information, contact Philips Medical Systems Nederland B.V. or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0005-2026.
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