Philips Ultrasound Transducer Probe Labeling Clarification on Useful Life
Philips Ultrasound is clarifying labeling on the SCNHD LA L7-4 HDI Transducer Probe to better define useful life. The clarification affects approximately 171,322 units distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recall addressing labeling clarification with no reported hazards, incidents, or patient impact. The issue is purely documentation-related regarding useful life definition.
Plain-English summary
Philips Ultrasound, Inc. is recalling the SCNHD LA L7-4 HDI Transducer Probe (Model No. 8500-8407-02, Serial Nos. 019MJ4 and 01N4RW) to provide clarification and updated labeling regarding useful life. Approximately 171,322 units were distributed nationwide.
The manufacturer is issuing this Class III FDA recall to provide improved labeling guidance that better defines the useful life of these ultrasound transducers in clinical use. The clarification ensures healthcare providers have clear documentation about transducer durability and proper use intervals.
Healthcare facilities and medical professionals should review the updated labeling provided by Philips regarding the defined useful life of these transducers to ensure appropriate equipment maintenance and replacement protocols.
The recalled product
- Product
- SCNHD LA L7-4 HDI Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-issue
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 (4)
- Model No. 8500-8407-02
- UDI: N/A
- Serial No. 019MJ4
- 01N4RW.
Distribution
Distributed nationwide across the United States.
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