Philips S7-2 Transducer Ultrasound Devices Recalled for Refurbishment

Plain-English summary

Philips Ultrasound, Inc. is recalling Philips S7-2 Transducer ultrasound devices. The devices were refurbished beyond their useful life, which may affect their performance and safety.

Approximately 5,230 units have been distributed nationwide in the United States and 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.

Patients or healthcare providers who have a Philips S7-2 Transducer with one of the affected model numbers or UDI codes should contact Philips Ultrasound, Inc. for further instructions. The FDA has classified this as a Class II recall.

The recalled product

Product

Philips S7-2 Transducer.

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Transducer

Hazard

• device-degradation
• refurbishment-defect

Affected units

5,230

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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