—#176670

Product

SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K173632
Affected lot / code info: software syngo CT VA20A_SP2 and active Guide&GO license

Why it was recalled

SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional procedures

Root cause (FDA determination)

Software design

Action the firm took

Siemens issued a Customer Safety Advisory Notice to customers via CT072/19 on 9/24/2019. The letter identifies the problem, health risk and action to take: To avoid this issue, please refrain from using the i-Sequence scan mode in combination with the 3x3 mm collimation until this issue has been solved. Please use the i-Sequence with the 3x5 mm collimation instead, as here the correct dose information will be shown. This issue will be resolved with an improved software version syngo CT VA20A_SP2b. The software update will be released, free of charge, with the update CT073/19/S for all affected systems. The software update release is planned for Q3/2019. All future service packs will contain the update as well. Questions: contact service organization at 1-800-888-7436.

Recalling firm

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

Distribution

Distribution pattern: US in the states of: GA, IN, MO, MS, NJ, OH, PA

Timeline

Recall initiated: 2019-09-24
Terminated: 2024-07-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176670. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.