The Recall Desk

FDA (Devices) recall action 83398

Siemens Medical Solutions USA, Inc. recalled 4 products on 2019-08-28

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2019-08-28
Critical
0
Units
5,585

Why these products were recalled

The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2019-08-28

    Siemens ACUSON NX3 Ultrasound Systems Recalled for Acoustic Output Power Defect

    Siemens is recalling ACUSON NX3 Elite ultrasound systems because internal testing found transducers may exceed defined acoustic output power values.

    Product
    ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004303 The ACUSON NX2 diagnostic ultrasound imaging systems are…
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2019-08-28

    Siemens ACUSON NX2 Ultrasound Systems Recalled for Acoustic Output Power Defect

    Siemens is recalling ACUSON NX2 ultrasound systems because internal testing found transducers may exceed defined acoustic output power values.

    Product
    ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications…
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2019-08-28

    Siemens ACUSON NX3 Ultrasound Systems Recalled for Acoustic Output Power Defect

    Siemens is recalling 1,384 ACUSON NX3 diagnostic ultrasound systems worldwide because internal testing found transducers may exceed defined acoustic output power values.

    Product
    ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004297 The ACUSON NX2 diagnostic ultrasound imaging systems are intended…
    Category
    Distribution
    43 states
  • ModerateFDA (Devices)··2019-08-28

    Siemens ACUSON NX2 Ultrasound Systems Recalled for Acoustic Output Defect

    Siemens is recalling 70 ACUSON NX2 ultrasound systems because internal testing found transducers may exceed defined acoustic output power values.

    Product
    ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications…
    Category
    Distribution
    43 states