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Recall Observatory FDA recall evidence

Device product

Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 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.

Z-2017-2016

April 22, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA Inc.
Event
Event 74192
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-2017-2016

Official wording

Reason: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

Code information: Serial Numbers: 72418,72428

Distribution pattern: Worldwide Distribution - US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.