S12-4 Transducer Probe Labeling Clarification for Useful Life Definition
Philips recalls 171,322 units of the S12-4 Transducer Probe to provide clarification and updated labeling that defines the useful life of ultrasound 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 focused on clarification and labeling of device useful life rather than a safety defect or hazard. No illnesses, injuries, or explicit safety risks are reported. Per the rubric, documentation issues without reported harm are scored as Low.
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 units of the S12-4 Transducer Probe, an ultrasound transducer device used for medical imaging applications. The devices have been distributed nationwide in the United States.
The recall is issued to provide clarification and improved labeling that specifies the useful life of the transducer probes during field operation. Current product labeling does not adequately define the operational lifespan and lifecycle guidance for the device.
Healthcare facilities and medical providers using the S12-4 Transducer Probe should consult updated product labeling from Philips Ultrasound, Inc. for revised information regarding the device's useful life, proper operational use, and lifecycle management.
The recalled product
- Product
- S12-4 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-deficiency
- documentation-deficiency
- useful-life-unspecified
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 (9)
- Model No. 989605361892
- 989605361892
- 989605361973
- 989605438411
- 989605387411
- 989605361971
- 989605387431
- 989605400802
- 989605440782
Distribution
Distributed nationwide across the United States.
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