Philips C6-3 Transducer Probe Labeling Clarification on Useful Life
Philips is providing labeling clarification to define the useful life of C6-3 Transducer Probes in the field. 171,322 units are affected nationwide.
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: This is an FDA Class III voluntary precautionary recall focused on labeling clarification regarding product useful life. No hazards, injuries, or illnesses are reported in the source. Labeling issues on medical devices without reported incidents are classified as moderate.
Plain-English summary
Philips Ultrasound, Inc. is providing labeling clarification to define the useful life of C6-3 Transducer Probes. The affected models are 989605359593, 989605387371, 989605359594, and 989605359591, with specific serial numbers and batch codes identified in the recall notice.
Approximately 171,322 units of the C6-3 Transducer Probe have been distributed nationwide in the United States. The recall is issued to clarify labeling information regarding the useful life of these ultrasound transducers.
Healthcare providers and users of the C6-3 Transducer Probe should refer to the updated labeling from Philips regarding the device's useful life. For more information about the clarified labeling or to confirm whether a specific device is affected, contact Philips Ultrasound, Inc.
The recalled product
- Product
- C6-3 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-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. 989605359593
- 989605387371
- 989605359594
- 989605359591
- UDI: (01)00884838067950(21)B20N4N
- (01)00884838067950(21)B1WR9H
- (01)00884838067950(21)B1RGN0
- (01)00884838067950(21)B1MTT4
- (01)00884838067950(21)B1N3C4
- (01)00884838087170(21)B27LPZ
- (01)00884838087170(21)B3W5CM
- (01)00884838067950(21)B24KL3
- (01)00884838067950(21)B1MTT5
- (01)00884838087170(21)B27LQ2
- Serial No. B20N4N
- B1WR9H
- B1RGN0
- B1MTT4
- B16QBM
- B1N3C4
Distribution
Distributed nationwide across the United States.
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