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 purpose of determining various metabolic (molecular) and physiologic functions within the human body; and Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.
FDA Recall Z-1424-2017 · Posted 2017-02-28
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Recalling FirmSiemens Medical Solutions USA Inc.
Recall StatusTerminated
Product CodeKPS
Date Initiated2017-02-20
Date Terminated2017-09-17
Product Quantity9 units
Reason for Recall
The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
Firm Action
Siemens sent a Customer Advisory Notice letter on February 20, 2017 to affected customer. The letter identified the affected product, problem and actions to be taken. For questions contact your local Siemens.
Root Cause
Labeling Change Control
Distribution Pattern
Worldwide distribution - US Nationwide in the states of CA, CT, FL, GA, IL, KY, MA, MI, ND, NJ, OH, OK, OR, PA, TN, WA, WI, WY and the countries of Switzerland, Great Britain, Italy
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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