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
- TEE Ultrasound Transducer
- Model numbers
- Model No. 989605440792, UDI: (01)00884838067660(21)02P8MV, Serial No. 02P8MV, 02MH3J.
- 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 OMNI II is an ultrasound system component used in diagnostic imaging. This recall targets the transducer component, not the entire system.
Why This Is Dangerous
The issue relates to labeling about useful life. It is not described as a device failure that could harm patients, but correct lifecycle labeling is essential for safe use and service decisions.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics with the affected transducers should stop use and consult Philips for replacement or corrective actions. No injuries have been reported.
Practical Guidance
How to identify if yours is affected
- Review the model numbers and identifiers on the device: Model No. 989605440792; UDI: (01)00884838067660(21)02P8MV; Serial No. 02P8MV; 02MH3J.
- Cross-check with the recall listing on the FDA enforcement page.
- If matched, stop use and contact Philips Ultrasound, Inc or your provider for instructions.
Where to find product info
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1623-2026
What timeline to expect
Not stated by the recall. Philips will provide updates as available.
If the manufacturer is unresponsive
- Escalate to hospital risk management or device safety office.
- Document all attempts to contact Philips and the provider.
How to prevent similar issues
- Verify labeling and lifecycle guidance during procurement.
- Work with clinical engineering to verify device lifecycle policies.
- Request formal replacement or service options from Philips for lifecycled devices.
Documentation advice
Keep recall notice, serial numbers, and all communications. Photograph any labeling changes and maintain a file for audit or vendor follow-up.
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Product Details
Model No. 989605440792; UDI: (01)00884838067660(21)02P8MV; Serial No. 02P8MV; 02MH3J. Distribution: US nationwide. Recall date: 2025-09-05. Quantity: 2 units. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- UDI: (01)00884838067660(21)02P8MV
- Serial No. 02P8MV
- US nationwide distribution
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