CLASS II ONGOING Device recall · Reported 9 Jul 2025 · FDA Enforcement Report

Philips eL18-4 EMT Transducer recalled by Philips Ultrasound

Philips Ultrasound is recalling Philips eL18-4 EMT Transducer, distributed nationwide in the US. The recall was initiated on 28 May 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No.989605431531; UDI: (01)00884838070806(21)B29W3Y; Serial No. B29W3Y.

Quantity recalled5,230 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2053-2025
FDA event ID: 96994
Recalling firm: Philips Ultrasound, Reedsville, PA
Classification: Class II
Status: Ongoing
Recall initiated: 28 May 2025
FDA classified: 2 Jul 2025
Reported: 9 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 May 2025	Recall initiated by company
2 Jul 2025	Classified by FDA	+35 days
9 Jul 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Ultrasound transducer devices were refurbished beyond their useful life.

Product as listed by the FDA

Philips eL18-4 EMT Transducer.

Where it was distributed

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.

Nationwide

Questions about this recall

Is Philips eL18-4 EMT Transducer recalled?

Yes. Philips Ultrasound recalled Philips eL18-4 EMT Transducer on 28 May 2025. The recall is Class II and its status is Ongoing. Recall number Z-2053-2025.

Why was it recalled?

Ultrasound transducer devices were refurbished beyond their useful life.

Which lots are affected?

Model No.989605431531; UDI: (01)00884838070806(21)B29W3Y; Serial No. B29W3Y.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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