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Recall Observatory FDA recall evidence

Device product

Philips L17-5 Ultrasound Transducer

Z-1621-2026

September 05, 2025

Class III

Product summary

Firm
Philips Ultrasound, Inc
Event
Event 97643
Status
Ongoing
Classification
Class III
Quantity
2 units
Official record key
device-enforcement:Z-1621-2026

Official wording

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

Code information: Model No. 989605366371, 989605388061; UDI: N/A; Serial No. 03228X, 03360Q.

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.