PlainRecalls
FDA Devices Moderate Class II Terminated

SOMATOM go.Now (Model #11061620), 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 planni

Reported: July 10, 2019 Initiated: May 28, 2019 #Z-1916-2019

Product Description

SOMATOM go.Now (Model #11061620), 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.

Details

Units Affected
53
Distribution
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.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled? ▼
SOMATOM go.Now (Model #11061620), 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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 53.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2019. Severity: Moderate. Recall number: Z-1916-2019.

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