What Happened

Philips Ultrasound, Inc. is initiating a recall to provide clarification and labeling that defines the useful life of the Philips OMNI II TEE Ultrasound Transducer. This is a Class III recall, voluntarily initiated by the firm.

Which Products Are Affected

The affected product is the Philips OMNI II TEE Ultrasound Transducer. Specific details include: Model No. 989605440792; UDI: (01)00884838067660(21)02P8MV; Serial No. 02P8MV and 02MH3J. A total of 2 units are involved in this recall. The distribution was US Nationwide.

What You Should Do

Consumers should follow the initial firm notification, which is a letter, for further instructions. Contact Philips Ultrasound, Inc. at their address: 1 Echo Dr, Reedsville, PA 17084-8603, for information on returns or refunds related to this recall.

Why This Matters

This recall addresses potential issues with product labeling to ensure proper use, which is important for maintaining the safety and effectiveness of medical devices in healthcare settings.

Source

Attribution: FDA. For more information, visit the FDA website and search for recall number Z-1623-2026.