Skip to content
Recall Observatory FDA recall evidence

Device product

Philips X7-2 Ultrasound Transducer

Z-1628-2026

September 05, 2025

Class III

Product summary

Firm
Philips Ultrasound, Inc
Event
Event 97643
Status
Ongoing
Classification
Class III
Quantity
5 units
Official record key
device-enforcement:Z-1628-2026

Official wording

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

Code information: Model No. 989605388121, 989605347571, 989605347573; UDI: (01)00884838061729(21)0344RZ; Serial No. 03FG1T, 031LM2, 032Q7G, 0344RZ, 033VM9.

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.