The Recall Desk

FDA (Devices) recall action 80586

Siemens Medical Solutions USA, Inc recalled 2 products on 2018-08-22

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
2018-08-22
Critical
0
Units
1,210

Why these products were recalled

Potential hardware issue which may cause thermal effects and possible damage to system parts.

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)··2018-08-22

    Siemens Artis Q. Angiography System Recalled for Potential Hardware Thermal Issue

    Siemens Medical Solutions is recalling 605 Artis Q. angiography systems due to a potential hardware issue that may cause thermal effects and damage to system parts.

    Product
    Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not l
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-08-22

    Siemens ARTIS Pheno X-Ray System Recalled for Potential Hardware Thermal Issue

    Siemens Medical Solutions USA is recalling 605 ARTIS Pheno interventional fluoroscopic X-ray systems due to a potential hardware issue that may cause thermal effects and damage to system parts.

    Product
    ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients
    Category
    Distribution
    0 states