Philips Ultrasound L12-5 Transducer Probe Recall for Labeling Clarification
Philips is recalling 171,322 L12-5 ultrasound transducer probes distributed nationwide to provide clarification and proper labeling defining the device's useful life.
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 device recall focused on labeling clarification with no reported injuries or illnesses. The recall addresses proper documentation of device lifespan to ensure appropriate use.
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 TRANSDUCER L12-5 Transducer Probe units distributed nationwide to provide clarification and labeling that defines the useful life of these devices.
Customers in possession of these transducers should review the clarified labeling from Philips Ultrasound, Inc. to understand the device's defined useful life and retirement timeline. Contact Philips Ultrasound, Inc. directly with questions about the recall.
The recalled product
- Product
- TRANSDUCER L12-5 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- mis-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 (3)
- Model No. 989605408174
- UDI: N/A
- Serial No. B1D3VM.
Distribution
Distributed nationwide across the United States.
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