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
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 Ultrasound
- Product type
- Ultrasound Transducer
- Model numbers
- Model No. 989605365021, UDI: N/A, Serial No. 033DZ4.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 5, 2025
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
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
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.
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
- Identify model 989605365021 and serial number 033DZ4 on the device.
- Confirm whether your device matches the recalled unit by cross-checking the model and serial numbers.
- 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.
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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
- Serial No. 033DZ4
- US nationwide distribution
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Safety Guide
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