Z-1915-2019 Class II Terminated
FDA device recall Z-1915-2019 was initiated by Siemens Medical Solutions USA, Inc on May 28, 2019 and is designated Class II. Reason for recall: The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans. The recall status is terminated (terminated March 31, 2023). Affected quantity: 9.
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2019
- Initiation Date
- May 28, 2019
- Termination Date
- March 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
Product Description
SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.
Reason for Recall
The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
Distribution Pattern
US Nationwide distributed in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and Puerto Rico.
Code Information
Serial Number: 112552 112551 112555 112519 112542 112545 112541 112536 112573