—#173751

Product

SOMATOM go.All, Model No. 11061638 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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K173632
Affected lot / code info: 118151

Why it was recalled

The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.

Root cause (FDA determination)

Software design

Action the firm took

On June 4, 2019, the firm notified customers of the recall via Urgent Medical Device Correction letters. Customers were informed that the firm has developed software update CT VA20A-SP2A to ensure uninterrupted scanning workflows and to reduce the number of user notifications. This update will also improve some areas during the start-up and shut-down processes, as well as providing other improvements related to the system, examination and reconstruction processes, and dual energy and intervention . The corrective action will be provided free of charge and will be distributed via Update Instruction CT026/19P. This update will be performed remotely. If you have any questions, please contact our service organization at 1- 800-888-7436. Customers were asked to promptly notify and instruct all staff at their organizations who need to be aware of this notice. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product advisory notice. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide distribution in the states of AL CA CT FL GA IL IN KS KY LA ME MI MO MS NC ND NE NH NY OH OK SD TN TX VA and WI

Timeline

Recall initiated: 2019-06-04
Terminated: 2023-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173751. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.