HIGH

Philips 3D6-2 Ultrasound Transducer Recalled for Labeling Clarification (17 Units, 2025)

Philips recalled 17 units of the 3D6-2 Ultrasound Transducer distributed nationwide to healthcare facilities in the United States. The recall seeks to clarify labeling defining the transducer’s useful life. Clinicians and facilities should stop using the device immediately and follow Philips recall instructions.

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

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

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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

  1. Check device model and serial numbers against the recall list
  2. Locate the UDI printed on the device or packaging and compare
  3. If there is a match, stop using the device immediately
  4. Refer to the recall instructions mailed by Philips for remediation
  5. 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

Product Details

Brand: Philips Ultrasound Product: 3D6-2 Ultrasound Transducer Model numbers: 989605326521, 989605440872, 989605440871 UDI: (01)00884838067714(21)02Q19C; (01)00884838067714(21)02VF0G; (01)00884838067714(21)02DNKX; (01)00884838067714(21)02BXT7; (01)00884838067714(21)02TWD3; (01)00884838067714(21)02RRQX; (01)00884838067714(21)02HD9F Serial numbers: 02V8MV Quantity: 17 units Sold in: United States (nationwide distribution) Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 17 units recalled
  • US nationwide distribution
  • Model No. 989605326521; 989605440872; 989605440871
  • UDI: 01 00884838067714(21)02Q19C; 01 00884838067714(21)02VF0G; 01 00884838067714(21)02DNKX; 01 0088
  • Serial No. 02V8MV
  • Stop using immediately and follow recall instructions

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelLOW
Severity Score
2/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Model No. 989605326521
989605440872
989605440871
UDI: (01)00884838067714(21)02Q19C
(01)00884838067714(21)02VF0G
+15 more
Affected States
ALL
Report Date
April 1, 2026
Recall Status
ACTIVE

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