Philips C9-5EC Ultrasound Transducer Devices Recalled
Philips Ultrasound, Inc. is recalling Philips C9-5EC transducer devices that were refurbished beyond their useful life, which may affect device performance and safety.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall where devices were refurbished beyond their useful life, creating a risk of harm (device malfunction during diagnostic procedures) without any reported illnesses or injuries. Per the rubric, a risk-of-harm product without reported adverse events scores at most 3 (High).
Plain-English summary
Philips Ultrasound, Inc. is recalling the Philips C9-5EC Transducer. The devices were refurbished beyond their useful life, raising concerns about their functionality and reliability.
Approximately 5,230 units have been affected. The devices were distributed nationwide in 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 and facilities who have received these devices should contact Philips Ultrasound, Inc. for instructions on inspection, service, or replacement. Devices with the following serial numbers are included in the recall: 03307Y, 02KMNY, 02JC8C, and 02Q6LP.
The recalled product
- Product
- Philips C9-5EC Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- device-malfunction
- premature-wear
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Model No.989605440801
- UDI: N/A
- Serial No. 03307Y
- 02KMNY
- 02JC8C
- 02Q6LP.
Distribution
Distributed nationwide across the United States.
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