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Low riskFDA DeviceClass III

Philips X3-1 ultrasound transducer recalled for labeling clarification on device lifespan

Philips is clarifying labeling on certain X3-1 ultrasound transducers to better define their useful lifespan in clinical use. This affects a small number of devices distributed nationwide. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

  1. If you use a Philips X3-1 ultrasound transducer, verify the serial number matches the recall list
  2. Contact Philips for updated labeling or device guidance
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Philips X3-1 Ultrasound Transducer
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 11 products — see all of them.

Details

Units affected
17 units
Illnesses reported
None reported
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Classification
Class III
Recall number
Z-1627-2026

In the FDA's words

Description
Philips X3-1 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. 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, 02Q8R3, 02VLZV, 02WND0, 02ZWBH, 02GP3C, 02YHTG, 02YHPN, 03DTL6, 02JK1H, 02VMJ6, 035Z89, 031C21, 038NQC, 02JL3W, 03C066, 02JK8D. Distribution: US Nationwide distribution. Affected quantity: 17 units
Hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

11 products in this recall

Philips ultrasound transducers recalled for unclear useful-life labeling

Philips is recalling 11 ultrasound transducer models to clarify and update labeling that defines how long these devices are expected to remain in use. The recall was filed for clarification, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

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