Philips X6-1 Ultrasound Transducers Recalled for Refurbishment Beyond Useful Life

Plain-English summary

Philips Ultrasound, Inc. is recalling 5,230 Philips X6-1 Transducer units that were refurbished beyond their useful life. These ultrasound transducer devices are used in medical diagnostic applications.

The recalled devices include model numbers 989605409282, 989605438511, 989605357143, and 989605357141. Affected units are identified by specific batch and serial numbers listed in the official FDA recall notice. The devices were distributed domestically throughout the United States and internationally to over 50 countries including Canada, Australia, Japan, France, Germany, and the United Kingdom.

Devices that have been refurbished beyond the manufacturer's specified useful life may not meet performance specifications and could be unreliable. Healthcare facilities using these transducers should verify whether their devices are affected by checking the model and serial numbers against the official FDA recall information provided.

The recalled product

Product

Philips X6-1 Transducer.

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Diagnostic Ultrasound / Transducer

Hazard

• device-malfunction
• performance-degradation

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.

Related recalls