FDA-Device2026-04-01Class III

Philips X3-1 Ultrasound Transducer

Philips Ultrasound, Inc

Hazard

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

Sold states

US Nationwide distribution.

Affected count

17 units

Manufactured in

1 Echo Dr, Reedsville, PA, United States

Products

Philips X3-1 Ultrasound Transducer

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1627-2026

Original summary

Philips X3-1 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. 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. Distribution: US Nationwide distribution. Affected quantity: 17 units

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