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Terminated

SOMATOM Emotion 16 (10165977)

FDA Recall Z-2473-2018 · Posted 2018-03-30

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2018-02-01
Date Terminated2020-05-01

Reason for Recall

A potential risk of unnecessary radiation exposure due to a software issue

Firm Action

Customers were sent notification letter via USPS with Certified Mail Receipts and Electronic Receipts.

Root Cause

Software design

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023687SOMATOM EMOTION 6 CT SYSTEMSSiemens Medical Systems, Inc. · 2002-11-22

Official Source

View FDA Recall →

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

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