Product Wiki · Recalls · U.S. FDA — Device Enforcement

BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens… — recall Z-2014-2016

U.S. FDA — Device Enforcement · United States · 2016-04-22 · Class II

As described by U.S. FDA — Device Enforcement: 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.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2014-2016
Date of alert
2016-04-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions USA Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US Nationwide
Reported risk: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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