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. 989605388121, 989605347571, 989605347573, UDI: (01)00884838061729(21)0344RZ, Serial No. 03FG1T, 031LM2, 032Q7G, 0344RZ +1 more
- 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
Ultrasound transducers are probes used with ultrasound imaging systems to capture audio-visual patient data. They are essential for diagnostic imaging in hospitals and clinics.
Why This Is Dangerous
The recall focuses on clarifying labeling to define the useful life of the transducers, which is intended to prevent use beyond recommended lifespan and ensure patient safety.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Hospitals and clinics with the affected X7-2 transducers must halt use and follow manufacturer guidance. The recall affects a small batch, but it requires prompt action to avoid imaging interruptions.
Practical Guidance
How to identify if yours is affected
- Check for Philips X7-2 labeling on the transducer and packaging.
- Cross-check with healthcare facility inventory records.
Where to find product info
Serial numbers and model numbers appear on the transducer housing and associated packaging or documentation.
What timeline to expect
Refunds or replacements, if offered, may take weeks from the date of notification. Contact Philips for specifics.
If the manufacturer is unresponsive
- Escalate through hospital risk management or biomedical engineering.
- File a report with the FDA if appropriate and document the communications.
How to prevent similar issues
- Verify labeling information when acquiring new transducers.
- Maintain an updated inventory of device lifespans for critical imaging equipment.
Documentation advice
Keep the recall letter, packaging, photos of the model and serial numbers, and all correspondence with Philips.
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Product Details
Product: Philips X7-2 Ultrasound Transducer\nModel numbers: Model No. 989605388121; 989605347571; 989605347573; UDI: (01)00884838061729(21)0344RZ; Serial No. 03FG1T; 031LM2; 032Q7G; 0344RZ; 033VM9.\nQuantity: 5 units.\nDistribution: US nationwide.\nRecall date: 2025-09-05.\nManufacturer: Philips Ultrasound, Inc.\nPrice: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- U.S. nationwide distribution
- Model No. 989605388121 and numbers listed in recall
- Recall number Z-1628-2026
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