Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2052-2025·Announced 2025-07-09

Philips eL18-4 Ultrasound Transducers Recalled for Defective Refurbishment

Philips Ultrasound is recalling Philips eL18-4 Transducers because they were refurbished beyond their useful life, which may affect device performance and patient safety.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class II recall. The source states the transducers were refurbished beyond their useful life, which is a manufacturing/maintenance defect rather than an acute contamination or hazard with reported injuries. No illnesses or injuries are reported in the source text.

Plain-English summary

Philips Ultrasound, Inc. is recalling the Philips eL18-4 Transducer (Model No. 989605456291 and 989605431531) because the devices were refurbished beyond their useful life.

Approximately 5,230 units have been distributed nationwide in the United States and internationally to 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 Federation, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United Arab Emirates, Venezuela, and Vietnam.

If you have one of these transducers, contact Philips Ultrasound, Inc. immediately for instructions on replacement or repair. Do not continue to use a device that may no longer function reliably.

The recalled product

Product: Philips eL18-4 Transducer.
Manufacturer: Philips Ultrasound, Inc
Category: Medical Device — Ultrasound / Diagnostic Imaging
Hazard: device-defect
refurbishment-failure
Affected units: 5,230

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

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.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 recalled by Philips Ultrasound, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →

Same manufacturer · Philips Ultrasound, Inc

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