Z-0713-2018 Class II Terminated
FDA device recall Z-0713-2018 was initiated by Siemens Medical Solutions USA, Inc on October 2, 2017 and is designated Class II. Reason for recall: The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time. The recall status is terminated (terminated September 27, 2018). Affected quantity: 6.
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- October 2, 2017
- Termination Date
- September 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Reason for Recall
The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time.
Distribution Pattern
US Nationwide Distribution in the states of FL, MO, NY, TN
Code Information
Serial Numbers: 108054, 108059, 108062, 108069, 108076, 108077