FDAHealthJuly 3, 2025

Philips Ultrasound, Inc — Mini Multi TEE Transducer Probe

⚠️ To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: July 3, 2025

US Nationwide distribution.

What's affected?

Product: Mini Multi TEE Transducer Probe
Brand: Philips Ultrasound, Inc
Lot code: Model No. 989605439242, 21381A; UDI: (01)00884838067547(21)B0DTV4, (01)00884838067547(21)B01639, (01)00884838067547(21)B06NT3; Serial No. 0341YT, 0319CQ, 028NZW, B0RF1J, B0F31L, B0DTV4, B0C9XR, 02H0L8, B0KYGV, B01639, B06NT3, 03C68B, 03C8CW.

Additional details

Model No. 989605439242, 21381A; UDI: (01)00884838067547(21)B0DTV4, (01)00884838067547(21)B01639, (01)00884838067547(21)B06NT3; Serial No. 0341YT, 0319CQ, 028NZW, B0RF1J, B0F31L, B0DTV4, B0C9XR, 02H0L8, B0KYGV, B01639, B06NT3, 03C68B, 03C8CW.

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 171,322 units.

View original FDA notice →

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