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Recall Observatory FDA recall evidence

Device product

Biograph mCT Flow 40-4R, System Material Number 10529159. 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.

Z-0808-2015

November 13, 2014

Class II

Product summary

Firm
Siemens Medical Solutions USA Inc.
Event
Event 69897
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-0808-2015

Official wording

Reason: Possibility for system display freeze during CT interventional procedures.

Code information: Serial Number: 11002

Distribution pattern: Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Possibility for system display freeze during CT interventional procedures.