Philips Ultrasound Transducer Probe recalled for useful life labeling clarification
Philips Ultrasound is recalling 171,322 L10-4LAP Transducer Probes to provide labeling clarification on the transducers' useful life in the field.
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 a labeling deficiency for product useful-life clarification. No adverse events, injuries, or deaths have been reported; the recall is precautionary to ensure end-users have clear manufacturer guidance.
Plain-English summary
Philips Ultrasound, Inc. has recalled 171,322 L10-4LAP Transducer Probes distributed nationwide in the United States. The recall is to provide clarification and labeling to define the useful life of these ultrasound transducers in clinical use.
The affected units are Model No. 989605395602 with serial numbers B0WM1V and B0WM2G. Healthcare facilities and medical practices using these transducers should verify they have the affected units and contact Philips for updated labeling information.
Users should contact the manufacturer to obtain clear guidance on the useful life and proper maintenance of their transducers. No adverse events or injuries have been reported in connection with this recall.
The recalled product
- Product
- L10-4LAP Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-issue
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 (5)
- Model No. 989605395602
- UDI: (01)00884838061521(21)B0WM1V
- (01)00884838061521(21)B0WM2G
- Serial No. B0WM1V
- B0WM2G.
Distribution
Distributed nationwide across the United States.
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