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Terminated

Biograph mCT-X 4R, MATERIAL NUMBER 10248670 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 Recall Z-2005-2016 · Posted 2016-06-21

Recalling FirmSiemens Medical Solutions USA Inc.
Recall StatusTerminated
Product CodeKPS
Date Initiated2016-04-22
Date Terminated2017-05-08
Product Quantity83 units

Reason for Recall

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

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - US Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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