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Low riskFDA DeviceClass III

Philips 3D6-2 Ultrasound Transducer recalled for clarification on useful life labeling

Philips is clarifying and updating labeling on certain 3D6-2 Ultrasound Transducers to better define their useful life in the field. This affects a limited number of units distributed nationwide. No injuries have been reported.

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

What to do

  1. If you operate one of the affected transducers, contact Philips for updated labeling or guidance
  2. Review the serial numbers and UDI codes listed in the recall notice to determine if your unit is affected
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Philips 3D6-2 Ultrasound Transducer
Sold in
Nationwide
Made for
All ages (under 100 years)

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-1618-2026

In the FDA's words

Description
Philips 3D6-2 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Model No. 989605326521, 989605440872, 989605440871; UDI: (01)00884838067714(21)02Q19C, (01)00884838067714(21)02VF0G, (01)00884838067714(21)02DNKX, (01)00884838067714(21)02BXT7, (01)00884838067714(21)02TWD3, (01)00884838067714(21)02RRQX, (01)00884838067714(21)02HD9F; Serial No. 02V8MV, 02Q19C, 02DNGH, 02TWL6, 02P2LF, 031XK6, 02VF0G, 02HJ9Q, 02DNKX, 02BXT7, 02VHQZ, 02TWD3, 02NDCL, 02CBD4, 02RRQX, 02KWQ9, 02HD9F. 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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