Recalls / —

—#162931

Product

SOMATOM Emotion 6 (Model 10165888)

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K023687

Affected lot / code info

Serial No. 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2018-02-01

Posted by FDA

2018-03-30

Terminated

2020-05-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #162931. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.