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Terminated

Biograph mCT X-4R, System Material Number 10248670. 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.

FDA Recall Z-0809-2015 · Posted 2014-12-16

Recalling FirmSiemens Medical Solutions USA Inc.
Recall StatusTerminated
Product CodeKPS
Date Initiated2014-11-13
Date Terminated2015-07-09
Product Quantity8 units total

Reason for Recall

Possibility for system display freeze during CT interventional procedures.

Firm Action

The firm initiated their recall by certified mail on 11/13/2014.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123737BIOGRAPH MCT FAMILYSiemens Medical Solutions USA, Inc. · 2013-01-29

Official Source

View FDA Recall →

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

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