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Terminated

SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus

FDA Recall Z-0771-2021 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2020-11-24
Date Terminated2024-02-06
Product Quantity3044

Reason for Recall

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

Firm Action

Customer notification letters will be sent starting December 14, 2020 to all affected customers via Customer Advisory Notice CT057/20/S. The technical solution, software versionVB20A_SP3, will be distributed to all affected customers free of charge via CT056/20/S. For questions or technical support, contact your local application specialists or your local service/sales organization at 1-800-888-7436.

Root Cause

Software design

Distribution Pattern

US Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K173607SOMATOM Edge PlusSiemens Medical Solutions USA, Inc. · 2018-03-21K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016-08-24K121072SOMATOM DEFINITION FLASHSiemens Medical Systems, Inc. · 2012-05-08K103127SOMATOM DEFINITION ASSiemens Medical Solutions USA, Inc. · 2011-03-04

Official Source

View FDA Recall →

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

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