Philips C5-2 Ultrasound Transducer Probe Labeling Clarification on Useful Life
Philips is clarifying labeling for 171,322 C5-2 ultrasound transducer probes distributed nationwide to define the useful life of transducers in field 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 a labeling and documentation issue with no reported safety incidents, injuries, or illnesses. The recall seeks to clarify product labeling regarding useful life, which fits the definition of a documentation issue typical of low-severity recalls.
Plain-English summary
Philips Ultrasound, Inc. is recalling the C5-2 Transducer Probe due to a labeling issue affecting 171,322 units distributed nationwide across multiple model numbers and serial batches.
This FDA Class III recall is being issued to provide clarification and updated labeling information to define the useful life of ultrasound transducers in field use. The clarification helps healthcare facilities and users properly understand the operational lifespan and parameters for these devices.
Healthcare providers with affected devices should review the updated labeling information provided by Philips to ensure proper understanding of the product's useful life and correct device usage.
The recalled product
- Product
- C5-2 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. 989605358813
- 989605371711
- 989605371713
- 989605386651
- 989605387521
- 989605389241
- 989605389242
- 989605398211
- 989605399561
- 989605418972
- 989605430242
- 989605451181
- 989605454101
- 989803002675
- UDI: Unique Device Identifier (UDI)
- (01)00884838067424(21)B200XV
- (01)00884838067424(21)B2W963
- (01)00884838067424(21)B2XQ5R
- (01)00884838067424(21)B31MDB
- (01)00884838067424(21)B2BBY9
Distribution
Distributed nationwide across the United States.
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