Quick Facts at a Glance
- Recall Date
- September 5, 2025
- Hazard Level
- HIGH
- Brand
- Philips Ultrasound
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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. 989605366371, 989605388061, UDI: N/A, Serial No. 03228X, 03360Q.
- Sold at
- Unknown
- 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 L17-5 transducer is a diagnostic imaging probe used with compatible ultrasound systems in clinical settings. It helps clinicians visualize anatomy during exams.
Why This Is Dangerous
The recall centers on clarifying and labeling the device life expectancy so users replace or service devices correctly. It is a labeling issue rather than a reported device failure.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to review labeling, update inventory, and coordinate replacements if instructed by Philips.
Practical Guidance
How to identify if yours is affected
- Check device labeling for model numbers 989605366371 and 989605388061.
- Check serial numbers 03228X and 03360Q.
- Compare against the recall notice and FDA listing.
Where to find product info
Labels on the transducer or accompanying documentation; recall notice on FDA enforcement site.
What timeline to expect
Philips will provide instructions; no explicit timeline is published for refunds or replacements.
If the manufacturer is unresponsive
- Document all communication attempts with Philips.
- Escalate to hospital risk management or medical device safety office.
- Consider contacting the FDA if the process stalls.
How to prevent similar issues
- Verify labeling and lifecycles before procurement.
- Work with certified distributors to ensure recall status is current.
- Keep records of serial numbers and model numbers for future recalls.
Documentation advice
Keep the recall letter, model and serial numbers, dates, and all correspondence with Philips or hospital officials.
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Product Details
Model No. 989605366371; 989605388061; Serial No. 03228X; 03360Q. Sold through US nationwide distribution to hospitals and healthcare providers. Sold date and price not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Quantity: 2 units recalled
- Distribution: US nationwide
- Hazard: Labeling to define useful life
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Safety Guide
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