Two Philips Ultrasound L17-5 transducers distributed nationwide to hospitals are recalled. The recall targets labeling that defines the devices' useful life. Stop using the transducers and follow Philips Ultrasound's instructions. Hospitals should contact Philips Ultrasound for guidance.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips Ultrasound, Inc or your healthcare provider for instructions. Notification method: Letter
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Model No. 989605366371; 989605388061; Serial No. 03228X; 03360Q. Sold through US nationwide distribution to hospitals and healthcare providers. Sold date and price not disclosed.
The recall addresses labeling to define the useful life of ultrasound transducers in the field. There is no documented isolated injury tied to the labeling issue in the notice.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow the recall instructions provided by Philips Ultrasound. 3. Contact Philips Ultrasound, Inc or your healthcare provider for instructions. 4. Notification method: Letter.
Recall URL provided by FDA. Specific Philips contact details not disclosed in the notice.
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