Home/Recalls/FDA-Z-1618-2026
FDA DevicesClass III

Philips 3D6-2 Ultrasound Transducer

Published: April 1, 2026Recall ID: Z-1618-2026Category: devicesCountry: US

Reason for Recall / Hazard

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

Product Description & Identification

Philips 3D6-2 Ultrasound Transducer

Additional Source Details

FieldValue
CityReedsville
StatePA
Event id97643
Address 11 Echo Dr
Code infoModel 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.
Postal code17084-8603
Report date20260401
Product typeDevices
Product quantity17 units
Reason for recallTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20250905
Initial firm notificationLetter
Center classification date20260324

Overview

  • Recalling FirmPhilips Ultrasound, Inc
  • StatusOngoing
  • Risk LevelClass III
  • DistributionUS Nationwide distribution.
Official Agency Alert