Philips ultrasound transducers recalled due to refurbishment beyond useful life
Philips Ultrasound is recalling 5,230 eL18-4 ultrasound transducers that were refurbished beyond their intended useful life. The devices may not function reliably.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with potential functional failure due to aging beyond design life. No illnesses or injuries reported. Per the severity rubric, theoretical hazards without documented harm cap at severity 3.
Plain-English summary
Philips Ultrasound, Inc is recalling the eL18-4 EMT Transducer, an ultrasound imaging device. Approximately 5,230 units worldwide are affected.
The devices were refurbished beyond their designed useful life, which may affect their proper function.
The affected transducers were distributed nationally in the United States and to over 50 countries worldwide, including Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India, Japan, Mexico, New Zealand, South Africa, South Korea, Spain, the United Kingdom, and others.
Healthcare providers and practitioners who have received these units should contact Philips Ultrasound, Inc for further guidance and instructions regarding the affected devices.
The recalled product
- Product
- Philips eL18-4 EMT Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- device-failure
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 (3)
- Model No.989605431531
- UDI: (01)00884838070806(21)B29W3Y
- Serial No. B29W3Y.
Distribution
Distributed nationwide across the United States.
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