Philips OMNI II TEE Transducer Probe Labeling Recall for Useful Life Clarification
Philips Ultrasound is recalling 171,322 OMNI II TEE transducer probes nationwide to provide labeling clarification on product 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: This is a Class III medical device labeling recall with no reported incidents or injuries. The hazard is theoretical—potential device malfunction from use beyond intended useful life—but the recall is preventive in nature, issued to provide clarification and labeling guidance.
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 OMNI II TEE Transducer Probe units that were distributed nationwide in the United States. The affected units have serial numbers 02DBYL, 02P8MV, and 038CLG.
The recall is being issued to provide clarification and labeling to define the useful life of these ultrasound transducers. Proper labeling of product useful life ensures that the devices operate safely and effectively during clinical use.
Healthcare providers and facilities that use the affected transducers should obtain and follow the updated labeling information from Philips Ultrasound regarding the product's useful life. For specific instructions or additional information, users should contact Philips Ultrasound directly.
The recalled product
- Product
- OMNI II TEE Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-deficiency
- device-malfunction
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 (5)
- Model No. N/A
- UDI: N/A
- Serial No. 02DBYL
- 02P8MV
- 038CLG.
Distribution
Distributed nationwide across the United States.
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