Recalls / —
—#146748
Product
BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- FDA product code
- KPS — System, Tomography, Computed, Emission
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K141971
- Affected lot / code info
- Serial Numbers: 1021,1024,1027,1029,1030,1031,1032,1033,1034,1037,11044,11045,11046,11047,11048,11049
Why it was recalled
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
Siemens sent a Customer Safety Advisory Letter on April 22, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Siemens representative at the contact numbers provided in the letter.
Recalling firm
- Firm
- Siemens Medical Solutions USA Inc.
- Address
- 810 Innovation Dr, Knoxville, Tennessee 37932-2562
Distribution
- Distribution pattern
- Worldwide Distribution - US Nationwide
Timeline
- Recall initiated
- 2016-04-22
- Posted by FDA
- 2016-06-21
- Terminated
- 2017-05-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #146748. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.