Philips eL18-4 Ultrasound Transducers Recalled for Excessive Refurbishment
Philips Ultrasound is recalling 5,230 eL18-4 ultrasound transducers that were refurbished beyond their useful life, potentially affecting device reliability.
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 medical device recall with no reported injuries or illnesses. The hazard—device degradation from refurbishment beyond useful life—is precautionary and theoretical rather than an acute or actively reported harm.
Plain-English summary
Philips Ultrasound, Inc. is recalling the eL18-4 ultrasound transducer, a medical device component used in diagnostic ultrasound systems. Approximately 5,230 units are affected.
The recalled transducers were refurbished beyond their useful life. Devices refurbished beyond their designed service life may experience degradation and reduced reliability during clinical use.
The affected devices were distributed throughout the United States and internationally to numerous countries including Australia, Canada, China, France, Germany, India, Japan, Mexico, South Korea, and the United Kingdom.
Customers with affected transducers should contact Philips Ultrasound, Inc. to confirm receipt of recalled devices and to arrange for appropriate action, such as replacement or return of units.
The recalled product
- Product
- Philips eL18-4 Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- device-degradation
- reliability-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 (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.
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