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

Recall Z-1920-2019 — SOMATOM go.Now, Model No. 11061618 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

U.S. FDA — Device Enforcement · United States · 2019-06-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1920-2019
Date of alert: 2019-06-04
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): 11061618

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

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

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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