FDA Enforcement
Class II
Terminated
Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: 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-1998-2016
·
Reported June 22, 2016
Enforcement
- Recall Number
- Z-1998-2016
- Event ID
- 74239
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 22, 2016
- Initiation Date
- April 25, 2016
- Classification Date
- June 15, 2016
- Termination Date
- February 1, 2017
- Address
- 810 Innovation Dr, Knoxville, TN, 37932-2562, United States
Description
Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: 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
The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.
Code Info
Serial Numbers: 31125,31126
Distribution
Worldwide Distribution - US Nationwide and the countries of China and Malaysia.
Quantity
2 units