Z-2478-2018Class II

SOMATOM Spirit(Model 10045692 )

Name: Z-2478-2018 SOMATOM Spirit(Model 10045692 )
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-02-01
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-02-01 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Spirit(Model 10045692 ) on 2018-02-01. FDA classified it as Class II and gives the reason as "A potential risk of unnecessary radiation exposure due to a software issue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2478-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-01
Posted: 2018-03-30
Terminated: 2020-05-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Spirit(Model 10045692 )
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: A potential risk of unnecessary radiation exposure due to a software issue
Root cause tag: software
FDA root cause: Software design
Action: Customers were sent notification letter via USPS with Certified Mail Receipts and Electronic Receipts.
Distribution: Nationwide
Product codes and lots: Serial No. 31621 31245 79670 31092 31313 31611

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2478-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2472-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28
Z-2473-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28
Z-2474-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28
Z-2475-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28
Z-2476-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28
Z-2477-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28
Z-2478-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28

Product code JAK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)