—#173458

Product

SOMATOM go.All (Model #11061630), 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: Serial Number: 117515 117476 117529 117492 117501 117515 117500 117522 117523 117484 117498 117517 117512 117505 117479 117516 117510 117495 117482 117521 117496 117508 117533 117483

Why it was 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.

Root cause (FDA determination)

Software design

Action the firm took

Urgent Medical Device Correction letters dated 5/24/19 were sent to customers.

Recalling firm

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

Distribution

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.

Timeline

Recall initiated: 2019-05-28
Terminated: 2023-03-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173458. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.