Home/Recalls/FDA-Z-1626-2026
FDA DevicesClass III

Philips S5-2 Ultrasound Transducer

Published: April 1, 2026Recall ID: Z-1626-2026Category: 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 S5-2 Ultrasound Transducer

Additional Source Details

FieldValue
CityReedsville
StatePA
Event id97643
Address 11 Echo Dr
Code infoModel No. 989605368393; (01)00884838064638(21)B0C824; Serial No. B0C824.
Postal code17084-8603
Report date20260401
Product typeDevices
Product quantity1 unit
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