Device product
3D6-2 Transducer Probe
Z-2346-2025
Product summary
- Event
- Event 97217
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 171,322 units
- Official record key
device-enforcement:Z-2346-2025
Official wording
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Code information: Model No. 989605440872, 8500-2032-01; UDI: N/A; Serial No. 031XK6, 02VF0G, 02M3N3, 031VQT, 03GKDF, 02TWD3, 02NDCL, 02CBD4, 02KWQ9.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.