Philips X7-2 Transducer Probes Recalled for Useful Life Labeling Clarification
Philips Ultrasound is recalling approximately 171,322 X7-2 Transducer Probes distributed nationwide to provide clarification and labeling regarding the useful life of these ultrasound devices.
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 an FDA Class III medical device recall with no reported illnesses, injuries, or adverse events. The issue is a labeling clarification regarding useful life definition. According to the severity rubric, Class III recalls are typically scored 1 or 2, and labeling corrections without reported harm are classified as Moderate (2).
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 units of the X7-2 Transducer Probe. The recall is issued to provide clarification and labeling to define the useful life of ultrasound transducers in the field. The affected transducers include multiple model numbers and UDI codes identified by the FDA.
The recalled devices were distributed nationwide in the United States. These ultrasound probes are medical devices used in ultrasound imaging systems in healthcare and clinical settings.
No reported adverse events or illnesses related to this labeling issue have been identified. The recall is a labeling correction to ensure proper understanding of the device useful life in clinical practice.
The recalled product
- Product
- X7-2 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-clarification
- useful-life
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. 989605400812
- 989605439971
- 989605347573
- 989605347571
- 989605388121
- UDI: (01)00884838061576(21)B2WXR8
- (01)00884838061576(21)B2X94P
- (01)00884838061576(21)B2YH00
- (01)00884838061576(21)B3RTXC
- (01)00884838061576(21)F01P42
- (01)00884838061576(21)F04HQ8
- (01)00884838061576(21)F06JLT
- (01)00884838061576(21)F06M72
- (01)00884838061576(21)F0FBV2
- (01)00884838061576(21)F0FF0X
- (01)00884838061576(21)F0GNFR
- (01)00884838061576(21)F00XMF
- (01)00884838061576(21)F05RCP
- (01)00884838061576(21)F0GNFP
- (01)00884838061576(21)B2FXP7
Distribution
Distributed nationwide across the United States.
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