CLASS II Device recall · Reported 9 May 2018 · FDA Enforcement Report

Somatom Emotion 6 Intended to produce cross-sections images recalled

Siemens Medical Solutions USA is recalling Somatom Emotion 6 Intended to produce cross-sections images of the body by computer, distributed nationwide in the US. The recall was initiated on 15 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes10046766

Quantity recalled1301

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1445-2018
FDA event ID: 79428
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 15 Feb 2018
FDA classified: 30 Apr 2018
Reported: 9 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

15 Feb 2018	Recall initiated by company
30 Apr 2018	Classified by FDA	+74 days
9 May 2018	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure

Product as listed by the FDA

SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

Where it was distributed

USA (nationally) Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

10046766

Where was it sold?

USA (nationally) Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

14 other products · FDA event 79428

This product is part of a recall event; the main page for the event is Somatom Spirit Intended to produce cross-sections images recalled.

Reported	Class	Recall	Company	Reason	Where
9 May 2018	CLASS II	Somatom Spirit Intended to produce cross-sections images recalled	Siemens Medical Solutions USA	Other	Nationwide
9 May 2018	CLASS II	Somatom Sensation Open Intended to produce cross-sections recalled	Siemens Medical Solutions USA	Other	Nationwide
9 May 2018	CLASS II	Somatom Scope Intended to produce cross-sections images recalled	Siemens Medical Solutions USA	Other	Nationwide
9 May 2018	CLASS II	Somatom Sensation 64 Intended to produce cross-sections recalled	Siemens Medical Solutions USA	Other	Nationwide
9 May 2018	CLASS II	Somatom Emotion (2003) Intended to produce cross-sections recalled	Siemens Medical Solutions USA	Other	Nationwide
9 May 2018	CLASS II	Somatom Perspective Intended to produce cross-sections recalled	Siemens Medical Solutions USA	Other	Nationwide
9 May 2018	CLASS II	Somatom Sensation 40 Intended to produce cross-sections recalled	Siemens Medical Solutions USA	Other	Nationwide
9 May 2018	CLASS II	Somatom Sensation Cardiac Intended to produce recalled	Siemens Medical Solutions USA	Other	Nationwide
9 May 2018	CLASS II	Somatom Scope Power Intended to produce cross-sections recalled	Siemens Medical Solutions USA	Other	Nationwide
9 May 2018	CLASS II	Somatom Emotion 16 Intended to produce cross-sections recalled	Siemens Medical Solutions USA	Other	Nationwide
9 May 2018	CLASS II	Somatom Perspective 16 Intended to produce cross-sections recalled	Siemens Medical Solutions USA	Other	Nationwide
9 May 2018	CLASS II	Somatom Emotion Duo (2003) Intended to produce recalled	Siemens Medical Solutions USA	Other	Nationwide
9 May 2018	CLASS II	Somatom Sensation 10 Intended to produce cross-sections recalled	Siemens Medical Solutions USA	Other	Nationwide
9 May 2018	CLASS II	Somatom Sensation 16 Intended to produce cross-sections recalled	Siemens Medical Solutions USA	Other	Nationwide

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8 Jul 2026Device	CLASS II	Artis icono floor recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
10 Jun 2026Device	CLASS II	Artis pheno recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	PA

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