HIGH

Philips Ultrasound C9-4 Transducer Recalled for Lifespan Labelling — 1 Unit (2025)

Philips Ultrasound recalled 1 unit of the C9-4 Ultrasound Transducer, Model No. 989605365021, distributed nationwide in the United States. The recall focuses on clarifying and labeling the device’s useful life. Healthcare providers and patients should stop using the device immediately and follow Philips’ instructions for replacement or further steps.

Quick Facts at a Glance

Recall Date
September 5, 2025
Hazard Level
HIGH
Brand
Philips Ultrasound
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips Ultrasound, Inc or your healthcare provider for instructions. Notification method: Letter

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About This Product

The C9-4 ultrasound transducer is a medical imaging probe used with ultrasound machines to visualize internal anatomy. It is a critical tool in clinical diagnostics and imaging across various specialties.

Why This Is Dangerous

The recall centers on clarifying and labeling the device’s useful life. Correct lifespan labeling helps ensure appropriate replacement decisions and device maintenance.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Impact is logistical and administrative for healthcare providers. It emphasizes correct labeling rather than immediate patient safety hazards.

Practical Guidance

How to identify if yours is affected

  1. Identify model 989605365021 and serial number 033DZ4 on the device.
  2. Confirm whether your device matches the recalled unit by cross-checking the model and serial numbers.
  3. Stop using the device if it matches the recall.

Where to find product info

Recall notice and guidance are available on the FDA enforcement page and through Philips Ultrasound customer service.

What timeline to expect

Timeline for refunds or replacements is not specified by the manufacturer in the data provided.

If the manufacturer is unresponsive

  • Escalate to your hospital's procurement or clinical engineering team.
  • If Philips is unresponsive, contact the FDA recall helpline for guidance.

How to prevent similar issues

  • Verify labeling on all ultrasound transducers before clinical use.
  • Stay informed about manufacturer recalls via FDA and vendor communications.
  • Maintain a list of devices and serial numbers to quickly identify recalled equipment.

Documentation advice

Keep the recall notice, model and serial numbers, and all correspondence with Philips or healthcare facilities for your records.

Product Details

Model No. 989605365021; Serial No. 033DZ4. UDI: N/A. Quantity: 1 unit. Distribution: US Nationwide.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 1 unit recalled
  • Model No. 989605365021
  • Serial No. 033DZ4
  • US nationwide distribution
  • Recall Date 2025-09-05
  • Status: ACTIVE

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
6/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Model No. 989605365021
UDI: N/A
Serial No. 033DZ4.
Affected States
ALL
Report Date
April 1, 2026
Recall Status
ACTIVE

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