Device product

Philips 3D6-2 Ultrasound Transducer

Z-1618-2026

September 05, 2025

Class III

Product summary

Firm: Philips Ultrasound, Inc
Event: Event 97643
Status: Ongoing
Classification: Class III
Quantity: 17 units
Official record key: device-enforcement:Z-1618-2026

Official wording

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

Code information: 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.

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.