Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1244-2019 — SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

U.S. FDA — Device Enforcement · United States · 2019-02-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1244-2019
Date of alert: 2019-02-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Medical Solutions USA, Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10590100

Reported risk: Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1244-2019 — SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

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