Philips XL14-3 Ultrasound Transducer Refurbished Beyond Useful Life
Philips Ultrasound, Inc. is recalling Philips XL14-3 Transducers because they were refurbished beyond their useful life, which may affect device performance and patient safety during ultrasound examinations.
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. The source text states only that transducers were refurbished beyond useful life with no reported illnesses or injuries. The hazard is performance-based degradation rather than an acute safety threat, placing it in the Moderate category per the rubric criteria for Class II recalls without reported adverse events.
Plain-English summary
Philips Ultrasound, Inc. is recalling approximately 5,230 units of the Philips XL14-3 Transducer (Model No. 989605409251) that were refurbished beyond their useful life. The transducers are ultrasound devices used in medical imaging.
The recalled transducers were 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, Türkiye, United Kingdom, United Arab Emirates, Venezuela, and Vietnam.
Refurbishment beyond the device's useful life may compromise the transducer's performance and reliability during clinical use. Patients and healthcare providers who have received or used these transducers should contact Philips Ultrasound, Inc. for guidance on replacement or return of affected units.
The recalled product
- Product
- Philips XL14-3 Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- device-performance
- refurbishment-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. 989605409251
- UDI: (01)00884838074613(21)B1ZL08
- Serial No. B1ZL08.
Distribution
Distributed nationwide across the United States.
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