Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brand
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Health & Personal Care
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product type
- Allura Centron PCI/mL Bleeding System (Cardiovascular imaging system component)
- Model numbers
- 722400
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 3, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
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
About This Product
Allura Centron is a cardiovascular imaging system used in interventional procedures. Model 722400 appears to be a component within this system.
Why This Is Dangerous
A BIOS battery that drains faster than expected can stop startup, leaving the system unusable with no warning messages to users.
Industry Context
This recall is not described as part of a broader safety pattern in the provided data.
Real-World Impact
The device being non-startable may interrupt critical imaging during procedures, requiring replacement or service.
Practical Guidance
How to identify if yours is affected
- Identify model number 722400 on the device label.
- Cross-check serial numbers against the list in the recall documentation (examples include 282, 91, 206, 472, 187, 486, 480, 71, 322, 280, 506, 429, 413, 497, 507, 502, 222, 103).
- Verify the device is part of Philips Allura Centron system family.
Where to find product info
Recall notification letters from Philips and internal medical device labeling on the front/back panels.
What timeline to expect
Remedies are issued via manufacturer recall notice; replacement or repair timelines not specified.
If the manufacturer is unresponsive
- Escalate to hospital safety officer.
- Contact Philips customer support and the FDA recall portal for updates.
How to prevent similar issues
- Verify BIOS components during equipment procurement.
- Monitor for firmware and BIOS updates from the manufacturer.
Documentation advice
Keep recall letter, serial numbers, date codes, and all communications. Document downtime and any service interruptions.
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Product Details
Model numbers: 722400. Serial numbers observed include 282, 91, 206, 472, 187, 486, 480, 71, 322, 280, 506, 429, 413, 497, 507, 502, 222, 103. Distribution: Worldwide, including US nationwide and multiple countries listed. Quantity: 313 units (OUS only). Associated 510(k) numbers: K102005, K130638, K130842, K133292, K141979, K162859, K161563.
Reported Incidents
No incident counts of injury or death are reported in the data provided.
Key Facts
- Model 722400; 313 units recalled (OUS).
- Global distribution includes US nationwide and 80+ countries listed.
- Hazard level: HIGH due to potential non-start of system; BIOS battery depletion cause.
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Safety Guide
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