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Recall Observatory FDA recall evidence

Device product

L12-5 38mm Transducer Probe

Z-2375-2025

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-2375-2025

Official wording

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

Code information: Model No. 989605428532; UDI: (01)00884838073623(21)B305XD, (01)00884838073623(21)F05R7X, (01)00884838073623(21)B1Y35V, (01)00884838073623(21)B305ZX, (01)00884838073623(21)F05K8W, (01)00884838073623(21)B3GWRJ, (01)00884838073623(21)B1Y306, (01)00884838073623(21)B1Y3CG, (01)00884838073623(21)B1Q699, (01)00884838073623(21)B1Y3C4, (01)00884838073623(21)B1RXWK, (01)00884838073623(21)B305X5, (01)00884838073623(21)B305ZK, (01)00884838073623(21)B3NFD5, (01)00884838073623(21)F034C6; Serial No. B305XD, F05R7X, B1Y35V, B305ZX, F05K8W, B3GWRJ, B1Y306, B1Y3CG, B1Q699, B1Y3C4, B1RXWK, B305X5, B305ZK, B3NFD5, F034C6.

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.