← FDA ENFORCEMENT
Z-1627-2026Class 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
17 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 X3-1 Ultrasound Transducer

Code / lot info

Model No. 989605440742, 989603002321, 989605388101, 989605440741; UDI: (01)00884838067615(21)033TVZ, (01)00884838067615(21)02Q8R3, (01)00884838067615(21)02VLZV, (01)00884838067615(21)02WND0, (01)00884838067615(21)02ZWBH, (01)00884838067615(21)02GP3C, (01)00884838067615(21)03DTL6, (01)00884838067615(21)02JK1H, (01)00884838067615(21)02VMJ6, (01)00884838067615(21)035Z89, (01)00884838067615(21)031C21, (01)00884838067615(21)02JL3W, (01)00884838067615(21)03C066, (01)00884838067615(21)02JK8D; Serial No. 033TVZ, 02Q8R3, 02VLZV, 02WND0, 02ZWBH, 02GP3C, 02YHTG, 02YHPN, 03DTL6, 02JK1H, 02VMJ6, 035Z89, 031C21, 038NQC, 02JL3W, 03C066, 02JK8D.

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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.