Philips Ultrasound Transducer Probe Useful Life Labeling Clarification
Philips Ultrasound is providing clarification on labeling for the C10-3v Transducer Probe to define the useful life of the product in clinical use.
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 addressing labeling clarification and documentation only. No safety hazard, injury, illness, or contamination is reported. The recall provides informational clarity about product useful life, which constitutes a documentation issue per the severity rubric.
Plain-English summary
Philips Ultrasound, Inc. is clarifying the labeling for the C10-3v Transducer Probe to provide clear definition of the useful life of ultrasound transducers in the field. This affects 171,322 units distributed nationwide in the United States.
The purpose of this recall action is to ensure healthcare facilities and practitioners have clear information regarding the useful life of these ultrasound probes. No manufacturing defect, safety hazard, or adverse events have been reported.
Facilities and clinicians using this product should refer to updated labeling materials from Philips Ultrasound for proper useful life guidance. Customers should contact Philips Ultrasound for information on obtaining updated labeling documentation.
The recalled product
- Product
- C10-3v Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-clarification
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. 989605409562
- 989605438521
- 989605381661
- 989605381663
- 989605398231
- 989605381662
- 989605409561
- 989605455171
- 989605492481
- 989605414531
- 989605406772
- 989605439232
- 21781A
- 989606708921
- 989605406771
- 989605414122
- UDI: (01)00884838061583(21)B1ZPMG
- (01)00884838061583(21)B3GL7D
- (01)00884838061583(21)B3PJJ1
- 010088483806158321F021FV
Distribution
Distributed nationwide across the United States.
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