S5-2 Transducer Probe Labeling Clarification to Define Useful Life
Philips is clarifying labeling on S5-2 ultrasound transducer probes to better define how long they can be safely used. The manufacturer is providing guidance to healthcare facilities on proper device replacement schedules.
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 a Class III FDA medical device recall focused on providing labeling clarification to define useful life parameters. No illnesses, injuries, or device failures are reported. The recall is administrative in nature, addressing a minor labeling issue to ensure proper device usage guidance.
Plain-English summary
Philips Ultrasound, Inc is issuing a labeling clarification for the S5-2 Transducer Probe, affecting approximately 171,322 units distributed nationwide in the United States. The recall addresses the need to provide clearer labeling and guidance on defining the useful life of these ultrasound transducers.
The purpose of this labeling clarification is to ensure that healthcare facilities and ultrasound technicians have adequate information about when these transducers should be retired from clinical use. Proper definition of useful life helps ensure continued diagnostic accuracy and appropriate device maintenance practices.
Healthcare facilities that use S5-2 Transducer Probes should review updated labeling materials from Philips regarding the useful life parameters. Facilities should implement appropriate device replacement schedules based on the clarified guidance to ensure transducers remain within their specified useful life during clinical use.
The recalled product
- Product
- S5-2 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. 989605412082
- 989605440682
- 989605388091
- 21314A
- 989605438581
- 989605361871
- 989605412081
- 989605961871
- 989605391922
- 989605387852
- 989605440752
- 989605412052
- 989605361892
- 989605384711
- 989605400802
- UDI: (01)00884838061637(21)B268VV
- (01)00884838061637(21)B2BK4Q
- (01)00884838061637(21)B2XV6D
- (01)00884838061637(21)B2XVMK
- (01)00884838061637(21)B3GLNL
Distribution
Distributed nationwide across the United States.
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