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Recall Observatory FDA recall evidence

Device product

C9-3v Transducer Probe

Z-2362-2025

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-2362-2025

Official wording

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

Code information: Model No. 989605366341; UDI: (01)00884838024304(21)B0LBJX, (01)00884838024304(21)B0LBXV; Serial No. B0DCXF, B0CT9W, 038VLZ, B0LBY2, 037RDB, B0DD3B, B0LBJX, B0LBXV, 037RG6, B0JDHK, B0BMR8.

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.