Philips eL18-4 EMT Ultrasound Transducers Recalled Due to Refurbishment Beyond Useful Life
Philips Ultrasound is recalling approximately 5,230 eL18-4 EMT ultrasound transducers that were refurbished beyond their useful life, which may affect device performance or 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: This is an FDA Class II recall involving a medical device with a condition (refurbishment beyond useful life) that presents a potential risk but with no reported injuries, hospitalizations, or illnesses documented in the source text. Class II recalls without adverse event reports are typically scored as Moderate per the rubric.
Plain-English summary
Philips Ultrasound, Inc is recalling the Philips eL18-4 EMT Transducer (Model No. 989605431531) distributed nationwide in the United States and internationally across numerous countries. Approximately 5,230 units of this medical ultrasound transducer device are affected by this recall.
The devices were refurbished beyond their useful life, which may impact their performance, safety, or ability to function as intended. The recall was initiated to address this manufacturing or refurbishment condition that could compromise device integrity.
Customers who possess affected eL18-4 EMT Transducers should contact Philips Ultrasound, Inc for further instructions regarding the return, replacement, or remediation of their devices. Healthcare facilities and users should immediately identify any affected transducers using the provided model and UDI information.
The recalled product
- Product
- Philips eL18-4 EMT 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 (3)
- Model No.989605431531
- UDI: (01)00884838070806(21)B29W3Y
- Serial No. B29W3Y.
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.
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