Philips S4-1 Ultrasound Transducers: Useful Life Labeling Clarification

Plain-English summary

Philips Ultrasound, Inc. is recalling 41 units of its S4-1 ultrasound transducer sold throughout the United States. The recall is being conducted to provide clarification and labeling to properly define the useful life of these transducers.

The recalled devices are identified by specific model numbers (989605458221, 989605458222, 989605477101) and serialized UDI codes listed on the FDA recall notice.

No injuries or adverse events have been reported. The FDA has classified this as a Class III recall. Healthcare providers using these transducers should refer to the FDA recall notice for affected unit identification and further guidance from Philips.

The recalled product

Product

Philips S4-1 Ultrasound Transducer

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Equipment

Hazard

• labeling-defect

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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