Summary
The FDA issued a Class II for Philips eL18-4 Transducer. by Philips Ultrasound, Inc. Reason: Ultrasound transducer devices were refurbished beyond their useful life..
Details
Source
Device Recall
External ID
Z-2052-2025
Action Date
2025-07-09
Status
Ongoing
Category
device
Product Description
Philips eL18-4 Transducer.
Lot/Code Info: 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.
Quantity Affected: 5,230 units
Reason for Recall
Ultrasound transducer devices were refurbished beyond their useful life.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-28
Company
Reedsville, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 153 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips Ultrasound, Inc has 111 FDA actions in our database, including 111 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Ultrasound, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Ultrasound, Inc have FDA actions?
Philips Ultrasound, Inc has 111 FDA actions in our database, including 111 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2052-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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