Philips X8-2t Ultrasound Transducers Refurbished Beyond Useful Life

Plain-English summary

Philips Ultrasound, Inc. is recalling approximately 5,230 X8-2t ultrasound transducers (model 989605455171) that were refurbished beyond their useful life. The recalled devices were distributed nationwide in the United States and internationally.

Devices refurbished beyond their useful life should not be placed back in use for patient care. Such devices may not function properly or meet performance specifications required for accurate diagnostic ultrasound imaging. Since these transducers are used for clinical diagnosis, degraded performance or malfunction could affect patient care.

Users with potentially affected transducers should contact Philips Ultrasound, Inc. to verify whether their equipment is included in this recall and for instructions on how to proceed. Users should cease use of any confirmed affected devices.

The FDA has classified this recall as Class II. For more information about this recall, healthcare providers and consumers can contact Philips Ultrasound, Inc. or visit the FDA's recall database.

The recalled product

Product

Philips X8-2t Transducer.

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Equipment

Hazard

• device-degradation
• 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.

Distribution

Distributed nationwide across the United States.

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