Philips 7.5MHz Endo Transducer Probe Recall for Labeling Clarification
Philips Ultrasound is clarifying labeling on 171,322 units of 7.5MHz Endo Transducer Probes to properly define device useful life. Devices were distributed nationwide.
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: FDA Class III recall for labeling clarification with no reported adverse events. Minor labeling issues warrant Moderate severity per the rubric.
Plain-English summary
Philips Ultrasound, Inc. is conducting a recall of 171,322 units of the 7.5MHz Endo Transducer Probe (Serial No. F00262) distributed nationwide in the United States.
The recall has been issued to provide clarification and improved labeling to define the useful life of these ultrasound transducers in the field.
This product is used for ultrasound diagnostic imaging. Customers with affected devices should contact Philips Ultrasound for updated labeling information regarding the useful life and proper use of these transducers.
The recalled product
- Product
- 7.5MHZ Endo Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling
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 (2)
- UDI: N/A
- Serial No. F00262.
Distribution
Distributed nationwide across the United States.
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