Philips Ultrasound, Inc. is recalling 212 ultrasound transducers across 11 different models to provide clarified labelling regarding their useful life in the field. This recall affects various types of transducers, including 3D, transesophageal (TEE), and sector array models. Consumers should be aware that this is a voluntary action by the firm to ensure proper device management and longevity information is available to users.
The recall is classified as low risk and is intended to provide healthcare providers with clearer instructions on the useful life of the devices. Without this clarification, there is a potential for improper maintenance or use beyond the intended operational lifespan, which could lead to suboptimal device performance.
17 units affected.
1 unit affected.
40 units affected.
2 units affected.
11 units affected.
2 units affected.
75 units affected.
41 units affected.
1 unit affected.
17 units affected.
5 units affected.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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