Philips 3D9-3v Ultrasound Transducer Probe Labeling Clarification on Useful Life
Philips is clarifying labeling on its 3D9-3v ultrasound transducer probes to define their useful life. The recall affects approximately 171,322 units distributed nationwide.
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 providing clarification of labeling regarding useful life of the device. No hazard, injury, illness, or death has been reported. The issue is documentation-related rather than a safety defect.
Plain-English summary
Philips Ultrasound, Inc. is clarifying the labeling on approximately 171,322 units of its 3D9-3v Transducer Probe, a medical ultrasound device. The clarification is intended to define the useful life of these transducers in clinical settings.
The recall was initiated to ensure that healthcare providers and clinical staff have clear information about when transducers should be replaced or serviced based on their useful life. This labeling clarification is part of a Class III recall from the FDA.
The affected devices were distributed nationwide in the United States. Healthcare facilities, hospitals, clinics, and providers using these transducer probes should verify their device serial numbers and lot codes against the FDA recall list.
Healthcare providers should review the updated labeling from Philips regarding the useful life of their 3D9-3v transducers and apply the new guidance to their device management protocols. For specific guidance, consult the official FDA recall notice at the provided URL.
The recalled product
- Product
- 3D9-3v Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-defect
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. 989605387181
- 989605389272
- 989605395621
- 989605395622
- 989605409562
- 989605412042
- 989605412082
- 989605415031
- 989605415032
- 989605418972
- 989605437982
- 989605438451
- 989605440832
- 989606714071
- 989606717071
- 989606750021
- 8500-1715-01
- UDI: Unique Device Identifier (UDI)
- (01)00884838061545(21)B3HM2J
- (01)00884838061545(21)B3FH50
Distribution
Distributed nationwide across the United States.
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