Philips X5-1 Transducer Probe Recalled for Useful Life Labeling Clarification
Philips is recalling X5-1 Transducer Probes to clarify labeling regarding the product's useful life. The manufacturer is providing updated labeling to clearly define when the device should no longer be used.
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 FDA Class III recall addresses labeling clarification for device useful life with no reported safety hazards or adverse events, fitting the Moderate category for minor labeling issues per the severity rubric.
Plain-English summary
Philips Ultrasound, Inc. is recalling the X5-1 Transducer Probe, a component used in ultrasound imaging systems. The recall is being issued to provide clarification and updated labeling that more clearly defines the useful life of the device.
Approximately 171,322 units have been distributed nationwide in the United States. The affected probes are identified by multiple model numbers and serial lot codes provided by the manufacturer.
Customers and healthcare facilities should review the updated labeling provided by Philips to understand the defined useful life of their X5-1 Transducer Probes and ensure proper device management and replacement according to the manufacturer's specifications.
The recalled product
- Product
- X5-1 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling
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. 989605400802
- 989605438491
- 989605353783
- 989605427811
- 989605353781
- 989605412052
- 989605455171
- 989605431531
- 989605412062
- 989605466031
- 989605409562
- 989605414122
- 989605412082
- UDI: (01)00884838061422(21)B23Y3N
- (01)00884838061422(21)B27BYD
- (01)00884838061422(21)B2FCRL
- (01)00884838061422(21)B32F76
- (01)00884838061422(21)B3MTPX
- N/A
- (01)00884838061422(21)B29NQ7
Distribution
Distributed nationwide across the United States.
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