Philips C5-1 Ultrasound Transducers Recalled for Refurbishment Beyond Useful Life
Philips Ultrasound is recalling 5,230 C5-1 ultrasound transducers that were refurbished beyond their useful life, risking device malfunction or degraded diagnostic performance. The devices were distributed nationally and to more than 50 countries.
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: FDA Class II recall for medical devices operated beyond their design life, presenting a real risk of device malfunction and unreliable diagnostic results. No injuries, illnesses, or device failures are reported in the source. This meets the rubric criterion for High: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips Ultrasound, Inc. is recalling approximately 5,230 Philips C5-1 Transducers, ultrasound diagnostic devices used in healthcare facilities.
The recalled transducers were refurbished beyond their useful life. Ultrasound transducers are engineered to operate within a defined lifespan; when refurbished and used beyond this design life, device components can degrade, potentially resulting in malfunction or unreliable diagnostic imaging performance.
The affected devices were distributed 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, Russia, 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 consumers with these transducers should contact Philips Ultrasound, Inc. immediately to determine the appropriate course of action, which may include device replacement, service verification, or removal from clinical use.
The recalled product
- Product
- Philips C5-1 Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- device-degradation
- malfunction
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 (20)
- Model No.989605412042
- 989605438541
- 989605365001
- 989605365003
- UDI: (01)00884838061613(21)B1M9V1
- (01)00884838061613(21)B13H1L
- Serial No. B1M9V1
- B142ZP
- B13H1L
- B1LGKZ
- B0T0M5
- 03DBJJ
- 036JBL
- B01RWL
- B01MZT
- 0393MP
- 03DWZC
- 03FVH9
- B02T1M
- 03BM2V
Distribution
Distributed nationwide across the United States.
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