Philips C5-2 Ultrasound Transducers Refurbished Beyond Useful Life

Plain-English summary

Philips Ultrasound, Inc. is recalling approximately 5,230 units of Philips C5-2 Transducers (Model Nos. 989605389242, 989605454101, 989605398211, 989605450353, 989605451181, 989605477131, 989605450351, and 989605450352). The transducers were refurbished beyond their useful life, which may affect device performance and safety.

The devices were distributed both domestically throughout the United States and internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United Arab Emirates, Venezuela, and Vietnam.

Healthcare providers, hospital administrators, and other facilities that use these transducers should immediately stop using the affected devices and contact Philips Ultrasound, Inc. for information regarding device replacement or remediation options.

The recalled product

Product

Philips C5-2 Transducer.

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Transducer

Hazard

• device-degradation
• performance-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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