Philips C8-4v Ultrasound Transducer Probe Labeling Clarification on Useful Life
Philips Ultrasound is providing clarification and updated labeling to define the useful life of C8-4v transducer probes. This is a labeling update affecting approximately 171,322 units distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall focused on providing labeling clarification about product useful life. The source text contains no reports of device failures, injuries, illnesses, or hospitalizations. The issue is documentation and labeling clarity rather than a physical product defect.
Plain-English summary
Philips Ultrasound, Inc. is issuing a clarification regarding labeling for the C8-4v Transducer Probe (Model No. 989803002685 and related variants) affecting approximately 171,322 units distributed nationwide in the United States. The company is providing updated labeling to clarify and define the useful life of these ultrasound transducers in clinical use.
The recall is intended to ensure that end-users and healthcare facilities have clear information about the product's useful life and appropriate lifespan. This update applies to multiple production lots and serial numbers identified by specific UDI (Unique Device Identifier) codes.
Healthcare facilities and end-users currently using these transducer probes should review the updated labeling information provided by Philips Ultrasound to understand the defined useful life of their devices. No product return or replacement is specified in this notice; users should contact Philips Ultrasound directly for detailed guidance on the labeling clarification.
The recalled product
- Product
- C8-4v Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-defect
- documentation-issue
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. 989803002685
- 989605416131
- 989605408153
- 989605430232
- 989605416141
- 989605364943
- 989605388111
- 989605387261
- 989605408151
- 989605361973
- 989605408141
- 989605430242
- 989605364941
- UDI: (01)00884838067745(21)B1YRNV
- (01)00884838067981(21)B35BZF
- (01)00884838067981(21)B24PBY
- (01)00884838067981(21)B27T4Z
- (01)00884838067981(21)B35H6L
- (01)00884838067981(21)B1RPRM
- (01)00884838068032(21)B2DGF2
Distribution
Distributed nationwide across the United States.
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