Device recall: SOMATOM Emotion 6 (Model 10165888)

Class II FDA enforcement event 79665. Recall start date: 1 Feb 2018. Status in the FDA record: Terminated. Termination date: 1 May 2020.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Siemens Medical Solutions USA, Inc started this device recall on 1 Feb 2018. The firm address in the FDA record is in Malvern, PA. FDA put the recall in Class II. FDA event 79665 has 7 product records. The first FDA enforcement report date is 8 Aug 2018. The record gives the status Terminated, with the termination date 1 May 2020.

FDA enforcement report The 7 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide

Recalling firm

Siemens Medical Solutions USA, Inc, Malvern, PA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

7 product records in the event.

FDA event 79665: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2472-2018	SOMATOM Emotion 6 (Model 10165888)	N/A	Class II	Terminated	8 Aug 2018
Z-2473-2018	SOMATOM Emotion 16 (10165977)	N/A	Class II	Terminated	8 Aug 2018
Z-2474-2018	SOMATOM Perspective (Model 10495568)	N/A	Class II	Terminated	8 Aug 2018
Z-2475-2018	SOMATOM Perspective 16 (Model 10891666)	N/A	Class II	Terminated	8 Aug 2018
Z-2476-2018	SOMATOM Scope ( Model 10967666)	N/A	Class II	Terminated	8 Aug 2018
Z-2477-2018	SOMATOM Scope Power (Model 10967888)	N/A	Class II	Terminated	8 Aug 2018
Z-2478-2018	SOMATOM Spirit(Model 10045692 )	N/A	Class II	Terminated	8 Aug 2018

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2018: 1,074
Share of these events in Class II: 92%
Product records in this event: 7Median of the firm: 1
Events of the firm on the register: 400

Other events of the firm

Other FDA enforcement events of Siemens Medical Solutions USA, Inc
Initiated	Product (first record)	Type	Class	Records
8 Jun 2026	ARTIS icono ceiling. Model Number: 11328100.	Device	Class II	1
20 May 2026	ARTIS icono biplane. Model Number: 11327600.	Device	Class II	3
12 Mar 2026	ARTIS Pheno VE30A and VE40A, Model 10849000	Device	Class II	1
10 Mar 2026	ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.	Device	Class II	1
9 Mar 2026	ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system	Device	Class II	2
29 Dec 2025	Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Vers	Device	Class II	2
19 Dec 2025	SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS	Device	Class II	4
5 Dec 2025	LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471	Device	Class II	1
24 Oct 2025	MAMMOMAT Revelation;	Device	Class II	3
1 Oct 2025	MAGNETOM Cima.X Upgrade. Model Number: 11689304.	Device	Class I	1

Siemens Medical Solutions USA, Inc: all 400 events

Official channels

FDA enforcement report Z-2472-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 79665. https://recallregister.com/fda/ii/79665/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide
What quantity of product is in FDA event 79665?: The event has 7 product records. The first record gives this quantity: N/A
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2018 have the same class?: 92% of the 1,074 device events that started in 2018 are in Class II.