Philips C5-2 Ultrasound Transducers Refurbished Beyond Useful Life
Philips Ultrasound, Inc. is recalling Philips C5-2 Transducers because they were refurbished beyond their useful life. The affected devices were distributed domestically nationwide and internationally across 49 countries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall. The source states the transducers were refurbished beyond useful life but does not report any injuries, illnesses, or hospitalization cases. Under the rubric, Class II recalls without reported harm fall into the Moderate (2) category.
Plain-English summary
Philips Ultrasound, Inc. is recalling approximately 5,230 units of Philips C5-2 Transducers (Model Nos. 989605389242, 989605454101, 989605398211, 989605450353, 989605451181, 989605477131, 989605450351, and 989605450352). The transducers were refurbished beyond their useful life, which may affect device performance and safety.
The devices were distributed both domestically 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, 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, hospital administrators, and other facilities that use these transducers should immediately stop using the affected devices and contact Philips Ultrasound, Inc. for information regarding device replacement or remediation options.
The recalled product
- Product
- Philips C5-2 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 (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.
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
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