Philips S9-2 Transducer Probe Recall for Useful Life Labeling Clarification

Plain-English summary

Philips Ultrasound, Inc. is recalling 171,322 S9-2 Transducer Probe units (Model Nos. 989605472101, 989605400802, and 989605361882) that were distributed nationwide in the United States. Multiple unit identification codes (UDI) are affected by this recall.

The purpose of this recall is to provide clarification and labeling to define the useful life of ultrasound transducers in the field. The additional labeling will help ensure that healthcare providers understand the appropriate service life and usage parameters for these devices.

Healthcare providers and facilities using the affected transducers should refer to Philips Ultrasound for updated labeling and product information regarding the useful life specifications of these devices.

The recalled product

Product

S9-2 Transducer Probe

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Transducer

Hazard

• labeling-issue

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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