The Recall Desk

FDA (Devices) recall action 76228

Siemens Medical Solutions USA Inc. recalled 4 products on 2017-03-15

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
2017-03-15
Critical
0
Units
37

Why these products were recalled

The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.

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

  • LowFDA (Devices)··2017-03-15

    Siemens Biograph Mobile PET/CT Recall for Missing Instructions

    Siemens Medical Solutions is recalling six Biograph Mobile PET/CT units because mobile-specific instructions were not shipped to a limited population of systems.

    Product
    Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of…
    Category
    Distribution
    18 states
  • ModerateFDA (Devices)··2017-03-15

    Siemens Biograph Mobile PET/CT Recall for Missing Instructions

    Siemens is recalling nine Biograph Mobile PET/CT systems because mobile-specific instructions were not shipped to a limited population of devices.

    Product
    Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the…
    Category
    Distribution
    18 states
  • ModerateFDA (Devices)··2017-03-15

    Siemens Biograph 6 TruePoint PET/CT Recall for Missing Instructions

    Siemens is recalling 18 Biograph 6 TruePoint mobile PET/CT systems because mobile-specific instructions were not shipped to a limited population.

    Product
    Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of…
    Category
    Distribution
    18 states
  • ModerateFDA (Devices)··2017-03-15

    Siemens Biograph Mobile PET/CT Recall for Missing Instructions

    Siemens is recalling four Biograph Mobile PET/CT units because specific mobile instructions were not shipped to a limited population.

    Product
    Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the…
    Category
    Distribution
    18 states