Z-1425-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2017
- Initiation Date
- February 20, 2017
- Termination Date
- September 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
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.
Reason for Recall
The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
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
Code Information
72484, 72490, 72516, 72536