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Philips Ultrasound, Inc: Philips 3D6-2 Ultrasound Transducer

Medical DevicesSource: FDA (device) · Date: 2026-04-01

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Philips Ultrasound, Inc
Product
Philips 3D6-2 Ultrasound Transducer
Reason / hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Classification
Class III
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2025-09-05
Code info
Model No. 989605326521, 989605440872, 989605440871; UDI: (01)00884838067714(21)02Q19C, (01)00884838067714(21)02VF0G, (01)00884838067714(21)02DNKX, (01)00884838067714(21)02BXT7, (01)00884838067714(21)02TWD3, (01)00884838067714(21)02RRQX, (01)00884838067714(21)02HD9F; Serial No. 02V8MV, 02Q19C, 02DNGH, 02TWL6, 02P2LF, 031XK6, 02VF0G, 02HJ9Q, 02DNKX, 02BXT7, 02VHQZ, 02TWD3, 02NDCL, 02CBD4, 02RRQX, 02KWQ9, 02HD9F.
Product quantity
17 units
Voluntary mandated
Voluntary: Firm initiated
City
Reedsville
State
PA
Country
United States
Event id
97643
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