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
- 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.
Lot numbers (6)
- Model No.989605440801
- UDI: N/A
- Serial No. 03307Y
- 02KMNY
- 02JC8C
- 02Q6LP.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 recalled by Philips Ultrasound, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 21 products in this recall →Related recalls
Same manufacturer · Philips Ultrasound, Inc
See all →- LowPhilips 3D6-2 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips S4-1 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips X7-2 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips C9-4 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips OMNI III TEE transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereGEM Premier 5000 PAK Lysing Solution Concentration Recall
FDA (Devices) · 2026-08-12