—#152552

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 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 product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K141971
Affected lot / code info: 72444, 72470, 72476, 72480, 72487, 72494, 72515, 72526, 72545

Why it was recalled

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

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA Inc.
Address: 810 Innovation Dr, Knoxville, Tennessee 37932-2562

Distribution

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

Timeline

Recall initiated: 2017-02-20
Posted by FDA: 2017-02-28
Terminated: 2017-09-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152552. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.