Philips Ultrasound, Inc: Device Recall

Recall Details

Recall Number

Z-2053-2025

Classification

Class II

Product Type

Device

Recalling Firm

Philips Ultrasound, Inc

Status

Ongoing

Date Initiated

05/28/2025

Location

Reedsville, PA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

5,230 units

Reason for Recall

Ultrasound transducer devices were refurbished beyond their useful life.

Product Description

Philips eL18-4 EMT Transducer.

Distribution Pattern

Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.

Other Recalls by Philips Ultrasound, Inc

• Class III: Low Risk 07/03/2025
  To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
• Class III: Low Risk 07/03/2025
  To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
• Class III: Low Risk 07/03/2025
  To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
• Class III: Low Risk 07/03/2025
  To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
• Class III: Low Risk 07/03/2025
  To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

View all recalls by Philips Ultrasound, Inc →