Philips Ultrasound recalled 2 units of the Philips OMNI II TEE Ultrasound Transducer sold nationwide through multiple retailers. The recall seeks labeling clarification to define the transducer's useful life. Healthcare facilities should stop using the devices and follow Philips recall instructions.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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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The Philips OMNI II is an ultrasound system component used in diagnostic imaging. This recall targets the transducer component, not the entire system.
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.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics with the affected transducers should stop use and consult Philips for replacement or corrective actions. No injuries have been reported.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1623-2026
Not stated by the recall. Philips will provide updates as available.
Keep recall notice, serial numbers, and all communications. Photograph any labeling changes and maintain a file for audit or vendor follow-up.
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.
No injuries or incidents have been reported.
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