SOMATOM Drive

• • Terminated Z-0771-2021 FDA Class II ·initiated 24 Nov 2020

  System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan

• • Terminated Z-3025-2020 FDA Class II ·initiated 22 Jun 2020

  Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan

• • Terminated Z-0406-2020 FDA Class II ·initiated 7 Oct 2019

  Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes

• • Terminated Z-2271-2019 FDA Class II ·initiated 3 Jul 2019

  Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

1. 24 Aug 2016 Cleared FDA 510(k) K161196
2. 3 Jul 2019 Recall initiated FDA recalls Z-2271-2019
3. 7 Oct 2019 Recall initiated FDA recalls Z-0406-2020
4. 22 Jun 2020 Recall initiated FDA recalls Z-3025-2020
5. 24 Nov 2020 Recall initiated FDA recalls Z-0771-2021

510(k) Number

K161196 ↗

FDA product code

JAK

Device class

Class II

Regulation

21 CFR Part 892.1750

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

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• Biograph Vision Quadra Combination

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