The Recall Desk

FDA (Devices) recall action 81144

Siemens Medical Solutions USA, Inc. recalled 2 products on 2018-10-24

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
2018-10-24
Critical
0
Units
968

Why these products were recalled

The terminals on the plug may become loose and overheat.

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)··2018-10-24

    Siemens Biograph Horizon PET/CT Scanners Recalled for Plug Overheating Risk

    Siemens Medical Solutions is recalling 78 Biograph Horizon PET/CT scanners because loose plug terminals may overheat.

    Product
    Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high…
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    0 states
  • SevereFDA (Devices)··2018-10-24

    Siemens Biograph mCT PET/CT Scanners Recalled for Plug Overheating Risk

    Siemens Medical Solutions is recalling 890 Biograph mCT PET/CT scanners because plug terminals may become loose and overheat.

    Product
    Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT…
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    Distribution
    0 states