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Terminated

SOMATOM Spirit(Model 10045692 )

FDA Recall Z-2478-2018 · 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

Official Source

View FDA Recall →

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

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