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Philips Azurion 7 B20 Interventional X-ray System Recall for 1,523 Units (2026)

Philips Medical Systems Nederland B.V. recalls 1,523 Azurion 7 B20 interventional X-ray systems used by hospitals nationwide after possible failure to initiate X-ray imaging. The defect affects whether imaging starts when using the wired foot switch. Hospitals should stop using the device and follow Philips recall instructions immediately.

Official notice
PhilipsHealth & Personal CareMedical DevicesSystem Code 722068System Code 722226System Code 722236

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
March 3, 2026
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
March 3, 2026
Hazard Level
HIGH
Brand
Philips
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Philips
Product type
Interventional Radiology X-ray System
Model numbers
System Code 722068, System Code 722226, System Code 722236, UDI 00884838085367, System Serial Numbers 547,178,467,335,147,205,170,455,494,564,418,95,440,247,225,64,149,42
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    March 3, 2026

  2. Reported by FDA DEVICE

    April 8, 2026

  3. RecallRadar source check

    April 15, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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

The Azurion 7 B20 is an interventional radiology X-ray system used for guided procedures in hospitals.

Why This Is Dangerous

A wired foot switch may fail to initiate X-ray imaging or trigger intermittent imaging during procedures, potentially impacting patient care.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Hospitals must stop using affected systems and coordinate with Philips for service or replacement; patient care workflows may be disrupted.

Practical Guidance

How to identify if yours is affected

  1. Review device labeling for System Code 722068, 722226, or 722236
  2. Verify UDI 00884838085367 and the System Serial Numbers listed.

Where to find product info

Device labeling and service documentation show System Code and UDI

What timeline to expect

Recall instructions should be followed. Timeline for replacement or service will vary by facility.

If the manufacturer is unresponsive

  • Escalate to hospital risk management
  • File a complaint with the FDA if the manufacturer is unresponsive
  • Consult hospital biomedical engineering for alternatives

How to prevent similar issues

  • Maintain an updated asset registry of interventional imaging systems
  • Work with vendor to ensure wired foot switch operation is validated during service visits
  • Review recall communications promptly

Documentation advice

Keep copies of recall notification, communications with Philips, and service records

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Product Details

Model codes: System Code 722068, 722226, 722236. UDI: 00884838085367. System Serial Numbers include 547, 178, 467, 335, 147, 205, 170, 455, 494, 564, 418, 95, 440, 247, 225, 64, 149, 42. Sold to hospitals and healthcare facilities nationwide. Sold since unknown. Price not disclosed.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 1,523 total units recalled
  • 322 units in US, 1,201 units outside US

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Brand
Model Numbers
System Code 722068
System Code 722226
System Code 722236
UDI 00884838085367
System Serial Numbers 547,178,467,335,147,205,170,455,494,564,418,95,440,247,225,64,149,42
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

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