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Terminated

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

FDA Recall Z-0265-2020 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2019-09-24
Date Terminated2024-07-08
Product Quantity14 US

Reason for Recall

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

Firm Action

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.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K173632SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GOSiemens Medical Solutions USA, Inc. · 2018-04-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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