FDA Recalls Philips mC7-2 Ultrasound Transducer Probe Labeling Clarification

Plain-English summary

Philips Ultrasound, Inc. is recalling 171,322 units of the mC7-2 Transducer Probe, a medical device used for ultrasound imaging. The device was distributed nationwide throughout the United States.

The recall has been issued to provide clarification and updated labeling that defines the useful life of ultrasound transducers in the field. This labeling update is intended to ensure clear communication of the device's useful life to healthcare providers.

Healthcare providers and facilities using these transducers should review the updated labeling materials provided by Philips. No injuries or illnesses related to this recall have been reported. Affected devices can be identified by model number 989605486021 and associated UDI codes.

The recalled product

Product

mC7-2 Transducer Probe

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Transducer

Hazard

• labeling-clarification

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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