Philips Ultrasound C5-2 Transducers Refurbished Beyond Useful Life
Philips Ultrasound is recalling 5,230 C5-2 Transducers that were refurbished beyond their useful life. The devices may not function reliably and have been distributed nationwide and internationally.
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 FDA Class II medical device recall addresses devices refurbished beyond their useful life, creating a reliability and performance risk for diagnostic equipment. No injuries, deaths, or illnesses have been reported; the hazard is potential device degradation and unreliable operation rather than an acute harm event.
Plain-English summary
Philips Ultrasound, Inc. is recalling the Philips C5-2 Transducer, an ultrasound diagnostic device used in medical imaging. The recall affects 5,230 units that have been refurbished and placed into service beyond their intended useful life.
Devices refurbished beyond their useful life may not operate reliably or meet the performance standards required for safe diagnostic imaging. Exceeding the designed service life creates a risk that equipment may degrade or malfunction during clinical use.
The affected devices have been distributed domestically throughout the United States and internationally to 53 countries, including Australia, Canada, China, France, Germany, India, Japan, Mexico, South Korea, United Kingdom, and many others.
Healthcare facilities and ultrasound centers should identify affected units using the provided model numbers and lot/serial codes. Organizations should follow Philips Ultrasound's instructions regarding device management, replacement, or repair of recalled units.
The recalled product
- Product
- Philips C5-2 Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- device-degradation
- reliability-loss
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.989605389242
- 989605454101
- 989605398211
- 989605450353
- 989605451181
- 989605477131
- 989605450351
- 989605450352
- UDI: (01)00884838067424(21)B36LWB
- (01)00884838067424(21)B2YZPM
- (01)00884838067424(21)B34JQB
- (01)00884838067424(21)F01L9N
- (01)00884838067424(21)B3V8CH
- (01)00884838067424(21)B3LJYB
- (01)00884838067424(21)B2C4FQ
- (01)00884838067424(21)F010MV
- (01)00884838067424(21)B3VGXG
- (01)00884838067424(21)F03968
- (01)00884838067424(21)B31MT5
- (01)00884838067424(21)B28T00
Distribution
Distributed nationwide across the United States.
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