Z-2052-2025 Class II Ongoing

Recalled by Philips Ultrasound, Inc — Reedsville, PA

Recall Details

Product Type
Devices
Report Date
July 9, 2025
Initiation Date
May 28, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,230 units

Product Description

Philips eL18-4 Transducer.

Reason for Recall

Ultrasound transducer devices were refurbished beyond their useful life.

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.

Code Information

Model No.989605456291, 989605431531; UDI: (01)00884838070813(21)B2JXFM, (01)00884838070813(21)B25L9M, (01)00884838070813(21)B25LJ0, (01)00884838070813(21)B25LY7, (01)00884838070806(21)B29W04; Serial No. B2JXFM, B25L9M, B28MJZ, B25LJ0, B25LY7, B29W04.