The Recall Desk

FDA (Devices) recall action 74239

Siemens Medical Solutions USA Inc. recalled 4 products on 2016-06-22

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
2016-06-22
Critical
0
Units
5

Why these products were recalled

The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.

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.

1–4 of 4

  • HighFDA (Devices)··2016-06-22

    Siemens Biograph mCT-S(64) 4R PET/CT Scanners Recalled for Cover Bracket Defect

    Siemens Medical Solutions USA Inc. is recalling two Biograph mCT-S(64) 4R PET/CT scanners because a cover bracket may not be welded, posing a risk of the cover falling during service.

    Product
    Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic informa
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-06-22

    Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts

    Siemens is recalling one Biograph mCT S(20) - 3R scanner because unwelded bolts on the cover-lifting bracket could cause the cover to fall during service.

    Product
    BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic infor
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-06-22

    Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts

    Siemens is recalling one Biograph mCT scanner because unwelded bolts on the cover-lifting bracket could cause the cover to fall during service.

    Product
    BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic infor
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-06-22

    Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts

    Siemens is recalling one Biograph mCT scanner because unwelded bolts may cause the cover to fall during service.

    Product
    BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic infor
    Category
    Distribution
    0 states