PlainRecalls
FDA Devices Moderate Class II Terminated

Biograph mCT S(40)-4R, System Material Number 10248671. 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.

Reported: December 24, 2014 Initiated: November 13, 2014 #Z-0811-2015

Product Description

Biograph mCT S(40)-4R, System Material Number 10248671. 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.

Reason for Recall

Possibility for system display freeze during CT interventional procedures.

Details

Units Affected
8 units total
Distribution
Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
Location
Knoxville, TN

Frequently Asked Questions

What product was recalled?
Biograph mCT S(40)-4R, System Material Number 10248671. 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.. Recalled by Siemens Medical Solutions USA Inc.. Units affected: 8 units total.
Why was this product recalled?
Possibility for system display freeze during CT interventional procedures.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 24, 2014. Severity: Moderate. Recall number: Z-0811-2015.