FDAHealthJuly 3, 2025

Philips Ultrasound, Inc — C9-3io Transducer Probe

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

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: July 3, 2025

US Nationwide distribution.

What's affected?

Product: C9-3io Transducer Probe
Brand: Philips Ultrasound, Inc
Lot code: Model No. 989605395612; UDI: (01)00884838061538(21)B2CYBN, (01)00884838061538(21)B0WM4Z, (01)00884838061538(21)B0WM4P; Serial No. B2CYBN, B0WM4Z, B0WM4P.

Additional details

Model No. 989605395612; UDI: (01)00884838061538(21)B2CYBN, (01)00884838061538(21)B0WM4Z, (01)00884838061538(21)B0WM4P; Serial No. B2CYBN, B0WM4Z, B0WM4P.

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 171,322 units.

View original FDA notice →

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