Philips Ultrasound recalled 17 X3-1 ultrasound transducers nationwide in the United States. The recall is to provide clarification and labeling to define the useful life of transducers in the field. Healthcare providers and patients should stop using the affected devices immediately and await further manufacturer instructions.
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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This product is a diagnostic imaging transducer used with Philips ultrasound systems to capture high-frequency ultrasound images.
The recall focuses on labeling and defining the device's useful life. There is no described immediate physical hazard in the notice.
This recall is not described as part of a broader industry pattern.
Hospitals may pause use of affected transducers while labeling updates are issued; no injuries reported.
FDA recall page and Philips Ultrasound customer service information.
The recall does not specify a replacement or refund timeline.
Keep the recall notice, model/UDI identifiers, serial numbers, correspondence with Philips, and dates of any actions taken.
Product: Philips X3-1 Ultrasound Transducer Models/Identifiers: Model No. 989605440742, 989603002321, 989605388101, 989605440741, UDI: (01)00884838067615(21)033TVZ, (01)00884838067615(21)02Q8R3, (01)00884838067615(21)02VLZV, (01)00884838067615(21)02WND0, (01)00884838067615(21)02ZWBH, (01)00884838067615(21)02GP3C, (01)00884838067615(21)03DTL6, (01)00884838067615(21)02JK1H, (01)00884838067615(21)02VMJ6, (01)00884838067615(21)035Z89, (01)00884838067615(21)031C21, (01)00884838067615(21)02JL3W, (01)00884838067615(21)03C066, (01)00884838067615(21)02JK8D; Serial No. 033TVZ; Additional identifier: 02Q
No injuries or incidents have been reported.
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