Device product

Mini Multi TEE Transducer Probe

Z-2385-2025

July 03, 2025

Class III

Product summary

Firm: Philips Ultrasound, Inc
Event: Event 97217
Status: Ongoing
Classification: Class III
Quantity: 171,322 units
Official record key: device-enforcement:Z-2385-2025

Official wording

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

Code information: 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.

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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