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

Biograph mCT Flow Edge-4R, System Material Number 10528955 — recall Z-0807-2015

U.S. FDA — Device Enforcement · United States · 2014-11-13 · Class II

As described by U.S. FDA — Device Enforcement: Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT 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-0807-2015
Date of alert
2014-11-13
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
Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
Reported risk: Possibility for system display freeze during CT interventional procedures.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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