CLASS II Device recall · Reported 4 Sep 2019 · FDA Enforcement Report

Somatom go.Now recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Somatom go.Now, distributed nationwide in the US. The recall was initiated on 31 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers

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-2399-2019
FDA event ID: 83556
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 31 Jul 2019
FDA classified: 27 Aug 2019
Reported: 4 Sep 2019
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

31 Jul 2019	Recall initiated by company
27 Aug 2019	Classified by FDA	+27 days
4 Sep 2019	Published in enforcement report	+8 days

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

Reason for recall

The injector holder could potentially fall off together with the injector and the storage box.

Product as listed by the FDA

SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data

Where it was distributed

US Nationwide Distribution in the states FL KS WI NE MS OH TX NY LA IN IL OK MI GA NJ AK CT AL MD

Nationwide Alaska Alabama Connecticut Florida Georgia Illinois Kansas Louisiana Maryland Michigan Mississippi Nebraska New Jersey New York Texas Wisconsin

Questions about this recall

Is Somatom go.Now recalled?

Yes. Siemens Medical Solutions USA recalled Somatom go.Now on 31 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2399-2019.

Why was it recalled?

The injector holder could potentially fall off together with the injector and the storage box.

Which lots are affected?

All serial numbers

Where was it sold?

US Nationwide Distribution in the states FL KS WI NE MS OH TX NY LA IN IL OK MI GA NJ AK CT AL MD

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

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
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

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled	Canon Medical System, USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederland B.v	Lead & Heavy Metals