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Z-1623-2026Class III

Philips Ultrasound, Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Philips Ultrasound, Inc
Product type
Device
Status
Ongoing
Report date
2026-04-01
Distribution
US Nationwide distribution.
Firm state
PA
Product quantity
2 units
Initiated by
Voluntary: Firm initiated
Reason for recall

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Product description

Philips OMNI II TEE Ultrasound Transducer

Code / lot info

Model No. 989605440792; UDI: (01)00884838067660(21)02P8MV; Serial No. 02P8MV, 02MH3J.

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →