FDA Enforcement
Class II
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.
Recall: Z-0809-2015
·
Reported December 24, 2014
Enforcement
- Recall Number
- Z-0809-2015
- Event ID
- 69897
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 24, 2014
- Initiation Date
- November 13, 2014
- Classification Date
- December 16, 2014
- Termination Date
- July 9, 2015
- Address
- 810 Innovation Dr, N/A, Knoxville, TN, 37932-2562, United States
Description
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.
Reason
Possibility for system display freeze during CT interventional procedures.
Code Info
Serial Number: 1003
Distribution
Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
Quantity
8 units total