Device product

C9-3io Transducer Probe

Z-2361-2025

July 03, 2025

Class III

Product summary

Firm: Philips Ultrasound, Inc
Event: Event 97217
Status: Ongoing
Classification: Class III
Quantity: 171,322 units
Official record key: device-enforcement:Z-2361-2025

Official wording

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

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

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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