Cardiac Imaging System Battery Depletion May Prevent Device Startup
Philips Cardio Vascular-Allura Centron cardiac imaging systems may have accelerated BIOS battery depletion that prevents the device from starting. Affected facilities should contact the manufacturer for battery replacement guidance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall with no reported injuries or illnesses. The hazard is operational failure—the device fails to start due to battery depletion—rather than direct patient harm. The recall is precautionary in nature.
Plain-English summary
The Philips Cardio Vascular-Allura Centron (Model 722400) is a cardiovascular imaging system used in medical facilities for diagnostic procedures.
The device's BIOS battery may deplete faster than anticipated during normal operation. When the battery is fully depleted, the system startup process halts and the device will not start. The system does not provide warning messages to alert users when the battery is low or depleted.
This recall affects 313 units distributed worldwide, including the United States and multiple other countries. Facilities should verify whether their facility operates an affected device.
Healthcare facilities with affected serial numbers should contact Philips Medical Systems Nederland B.V. for instructions on battery replacement and to ensure their devices are properly serviced before continued use.
The recalled product
- Product
- Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- battery-depletion
- 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 (20)
- Model Numbers: 722400
- UDI-DI: N/A
- Serial Numbers: 282
- 91
- 206
- 472
- 187
- 486
- 480
- 71
- 322
- 280
- 506
- 429
- 413
- 497
- 507
- 502
- 222
- 103
Distribution
Distributed nationwide across the United States.
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