Philips Ultrasound, Inc.: 3D9-3v Ultrasound Transducers Recalled for Chassis Bonding Failure

What You Should Do

1. Identify if your transducer is affected by checking the model name (3D9-3v Transducer) and the serial number on the device's connector or packaging.
2. Cross-reference your serial number against the 449 affected units, which include codes such as F07VBZ, F083JP, F086Z5, F088QC, F08JPF, F08K4H, and many others listed in the product details.
3. Verify the Unique Device Identifier (UDI-DI) code 00884838061545 located on the product labeling.
4. If you identify an affected transducer, contact Philips Ultrasound, Inc. at their Bothell, Washington headquarters or your local service representative to arrange for an inspection or replacement.
5. Consult with your healthcare facility's biomedical engineering department to ensure the device is removed from active clinical use until the manufacturer provides further instructions.
6. Contact Philips Ultrasound, Inc. or your healthcare provider for further instructions and potential refund or replacement options.
7. For additional questions or to report an issue, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products