Philips Ultrasound, Inc: Device Recall
Recall #Z-2052-2025 · 05/28/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2052-2025
- 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 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
- Class III: Low Risk 07/03/2025
- Class III: Low Risk 07/03/2025
- Class III: Low Risk 07/03/2025
- Class III: Low Risk 07/03/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.