Philips C6-2 Ultrasound Transducer Probes Labeling Clarification on Useful Life
Philips Ultrasound issued a nationwide recall of 171,322 C6-2 Transducer Probes to provide clarification and labeling defining the useful life of these ultrasound transducers.
What this means for you
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: FDA Class III recall involving labeling clarification to define the useful life of ultrasound transducers. No reported illnesses or injuries are mentioned in the source material. This is a documentation and labeling clarification action consistent with FDA Class III classification and typical moderate-severity recalls.
Plain-English summary
Philips Ultrasound, Inc. has recalled the C6-2 Transducer Probe, affecting 171,322 units distributed nationwide in the United States. The recall was initiated to provide clarification and labeling that defines the useful life of these ultrasound transducers in the field.
The purpose of this recall is to address the labeling of the device to ensure clear definition and communication of the product's useful life. This clarification applies to the specified model numbers and UDI codes identified by the manufacturer.
The affected devices were distributed to healthcare facilities and providers across the United States. Healthcare facilities using C6-2 Transducer Probes should ensure they have received and reviewed the updated labeling information from Philips regarding the device's useful life and follow all manufacturer guidance on proper use, maintenance, and handling.
For more information about the updated labeling or other aspects of this recall, healthcare providers should contact Philips Ultrasound directly.
The recalled product
- Product
- C6-2 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-deficiency
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. 989605418982
- 989605418983
- 989605463391
- 989605442151
- 989605387071
- 989605418972
- UDI: (01)00884838067868(21)B1N309
- (01)00884838067868(21)B1N3GM
- (01)00884838067868(21)B20LH9
- (01)00884838087163(21)B27M92
- (01)00884838087163(21)B2D4X5
- (01)00884838087163(21)B2TQDL
- (01)00884838087163(21)B2TQHL
- (01)00884838087163(21)B2TR9L
- (01)00884838087163(21)B2TR9R
- (01)00884838087163(21)B32NLQ
- (01)00884838087163(21)B32P57
- (01)00884838087163(21)B3WW8C
- (01)00884838087163(21)B40ZK4
- (01)00884838087163(21)F05J29
Distribution
Distributed nationwide across the United States.
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