Quick Facts at a Glance
- Recall Date
- September 5, 2025
- Hazard Level
- HIGH
- AI Risk Assessment
- LOW
- 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. 989605326521, 989605440872, 989605440871, UDI: (01)00884838067714(21)02Q19C, (01)00884838067714(21)02VF0G, (01)00884838067714(21)02DNKX, (01)00884838067714(21)02BXT7, (01)00884838067714(21)02TWD3 +12 more
- 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 Philips 3D6-2 Ultrasound Transducer is a diagnostic imaging component used in ultrasound systems. It is designed to convert electrical energy into ultrasound waves for imaging.
Why This Is Dangerous
The recall focuses on clarifying the useful-life labeling. It does not identify a direct patient hazard in the notice beyond the labeling requirement.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics with affected units must stop use and consult Philips for remediation. The immediate impact is administrative and logistical rather than a known safety incident.
Practical Guidance
How to identify if yours is affected
- Check device model and serial numbers against the recall list
- Locate the UDI printed on the device or packaging and compare
- If there is a match, stop using the device immediately
- Refer to the recall instructions mailed by Philips for remediation
- Contact Philips Ultrasound, Inc or your healthcare provider for next steps
Where to find product info
Use the official Philips recall notice and FDA enforcement page for the most accurate identifiers and instructions.
What timeline to expect
Remedies may take several weeks; processing is individualized by Philips.
If the manufacturer is unresponsive
- Document all contact attempts with Philips or your facilities' equipment manager
- File a complaint with the FDA if the company is unresponsive
- Consult legal counsel if needed for delayed remedies
How to prevent similar issues
- Register for recall alerts from manufacturers and regulators
- Verify device identifiers before installation or use
- Maintain a current inventory of ultrasound transducers and associated UDI/serial data
- Check labeling for useful-life information during procurement
Documentation advice
Keep the recall notice, serial numbers, model numbers, and all correspondence with Philips as part of your records
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution
- Serial No. 02V8MV
- Stop using immediately and follow recall instructions
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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