← FDA ENFORCEMENT
Z-1628-2026Class III

Philips Ultrasound, Inc

Recalling firm
Philips Ultrasound, Inc
Product type
Device
Status
Ongoing
Report date
2026-04-01
Distribution
US Nationwide distribution.
Firm state
PA
Product quantity
5 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

Product description

Philips X7-2 Ultrasound Transducer

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.