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.
What this means for you
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
- 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 →Related recalls
Same manufacturer · Philips Ultrasound, Inc
See all →- LowPhilips 3D6-2 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips S4-1 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips X7-2 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips C9-4 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips OMNI III TEE transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
Same hazard · device defect
See all →- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22