Cardiac imaging system may fail to start due to battery depletion
The Allura Xper FD10C cardiac imaging system may fail to start due to faster-than-expected BIOS battery depletion. No warning message appears before battery failure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device with a functional failure preventing system startup. Although no injuries or illnesses have been reported, a non-functioning cardiac imaging system represents a risk-of-harm product in clinical settings.
Plain-English summary
Philips Medical Systems is recalling the Allura Xper FD10C cardiac imaging system, Model 722001. The BIOS battery in these systems depletes faster than originally anticipated during the design phase.
When the battery is depleted, the system will not start and the startup process will be halted. Additionally, no user messages are displayed before the battery becomes low or depleted, preventing advance notification of the problem.
Two units are affected in the United States. The system has been distributed worldwide to numerous countries.
The recalled product
- Product
- Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- battery-failure
- system-startup-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model Number: 722003
- UDI-DI: N/A
- Serial Numbers: 19
- 21
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03