The Recall Desk

FDA (Devices) recall action 79740

Siemens Medical Solutions USA, Inc recalled 2 products on 2018-05-16

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2018-05-16
Critical
0
Units
184

Why these products were recalled

Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.

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.

1–2 of 2

  • HighFDA (Devices)··2018-05-16

    Siemens Syngo.plaza Software Recalled to Prevent Patient Misdiagnosis

    Siemens Medical Solutions is recalling 92 units of Syngo.plaza software to fix date formatting and annotation issues that could lead to patient misdiagnosis.

    Product
    Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2018-05-16

    Siemens Recalls Syngo.plaza Software to Prevent Patient Misdiagnosis

    Siemens Medical Solutions is recalling Syngo.plaza software due to format errors in study dates and issues with legacy presentation states that could lead to patient misdiagnosis.

    Product
    Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in
    Category
    Distribution
    0 states