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Recall Observatory FDA recall evidence

Device product

C6-3 Transducer Probe

Z-2356-2025

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-2356-2025

Official wording

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

Code information: Model No. 989605359593, 989605387371, 989605359594, 989605359591; UDI: (01)00884838067950(21)B20N4N, (01)00884838067950(21)B1WR9H, (01)00884838067950(21)B1RGN0, (01)00884838067950(21)B1MTT4, (01)00884838067950(21)B1N3C4, (01)00884838087170(21)B27LPZ, (01)00884838087170(21)B3W5CM, (01)00884838067950(21)B24KL3, (01)00884838067950(21)B1MTT5, (01)00884838087170(21)B27LQ2; Serial No. B20N4N, B1WR9H, B1RGN0, B1MTT4, B16QBM, B1N3C4, B27LPZ, 03DG3C, B3W5CM, B2ZN6B, B19M3K, B2TJFT, B35M7F, B24KL3, B1MTT5, B32P04, B35MC6, B27LQ2.

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.