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Recall Observatory FDA recall evidence

Device product

Philips Mini Multi TEE Ultrasound Transducer

Z-1622-2026

September 05, 2025

Class III

Product summary

Firm
Philips Ultrasound, Inc
Event
Event 97643
Status
Ongoing
Classification
Class III
Quantity
11 units
Official record key
device-enforcement:Z-1622-2026

Official wording

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

Code information: Model No. 989605439241, 989605439242, 21381A; UDI: (01)00884838067547(21)B093BQ, (01)00884838067547(21)B0988T, (01)00884838067547(21)02P6MY, (01)00884838067547(21)039M2Q, (01)00884838067547(21)0319CQ, (01)00884838067547(21)B01639; Serial No. 02GXR0, B093BQ, B0988T, 02P6MY, 039M2Q, 0341YT, 0319CQ, 028NZW, 02H0L8, B01639, 039M2M.

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.