Philips Medical Systems Nederland B.V. recalled 53 Allura Xper CV20 medical imaging systems on September 3, 2025. The BIOS battery may deplete faster than anticipated, halting the system's start-up process. Users will not receive warnings before the battery depletes.
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 product is the Allura Xper CV20, Model Number 722031. The recall affects 53 units distributed worldwide, including the US and several countries across Europe, Asia, and South America.
The BIOS battery in the Allura Xper CV20 may deplete faster than expected. When the battery is depleted, the system will not start, which could disrupt medical procedures.
No injuries or incidents have been reported related to this recall as of the report date. The risk level is classified as high due to potential disruptions in medical services.
Stop using the Allura Xper CV20 immediately. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0014-2026.
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