Philips Ultrasound L15-7IO Transducer Probe Labeling Clarification Recall
Philips is recalling 171,322 L15-7IO ultrasound transducer probes to provide clarification and labeling about the device's useful life.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses, injuries, or deaths. The recall is purely precautionary, addressing a labeling deficiency regarding device useful life. No actual harm has been reported or confirmed.
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 units of the L15-7IO TRANSDUCER Transducer Probe distributed nationwide in the United States.
The recall is being issued to provide clarification and labeling to define the useful life of these ultrasound transducers in the field.
Customers who have received these devices should consult with Philips Ultrasound, Inc. for updated labeling and guidance regarding the useful life of their transducers.
For more information about this Class III medical device recall, contact Philips Ultrasound, Inc.
The recalled product
- Product
- L15-7IO TRANSDUCER Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-deficiency
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. N/A
- UDI: N/A
- Serial No. B1K740.
Distribution
Distributed nationwide across the United States.
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