Device 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 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.
Z-1425-2017
Product summary
- Event
- Event 76228
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1425-2017
Official wording
Reason: The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
Code information: 72484, 72490, 72516, 72536
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
Derived failure modes
-
Unknown
The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.