—#131921

Product

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 product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123737
Affected lot / code info: Serial Number: 1003

Why it was recalled

Possibility for system display freeze during CT interventional procedures.

Root cause (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: Siemens Medical Solutions USA Inc.
Address: 810 Innovation Dr, Knoxville, Tennessee 37932-2562

Distribution

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

Timeline

Recall initiated: 2014-11-13
Posted by FDA: 2014-12-16
Terminated: 2015-07-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131921. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.