CLASS II Device recall · Reported 29 Mar 2017 · FDA Enforcement Report

Artiste" MV System recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Artiste" MV System, distributed nationwide in the US. The recall was initiated on 14 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDevice Model# 8139789

Quantity recalled80 systems

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-1488-2017
FDA event ID: 76712
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 14 Feb 2017
FDA classified: 20 Mar 2017
Reported: 29 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

14 Feb 2017	Recall initiated by company
20 Mar 2017	Classified by FDA	+34 days
29 Mar 2017	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

Software update

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

ARTISTE" MV System

Where it was distributed

Distributed throughout the United States

Nationwide

Questions about this recall

Why was it recalled?

Software update

Which lots are affected?

Device Model# 8139789

Where was it sold?

Distributed throughout the United States

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.

Other products in this recall event

3 other products · FDA event 76712

This product is part of a recall event; the main page for the event is Oncor" Avant-garde recalled by Siemens Medical Solutions USA.

Reported	Class	Recall	Company	Reason	Where
29 Mar 2017	CLASS II	Oncor" Avant-garde recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
29 Mar 2017	CLASS II	Oncor" Expression Oncor" Impression Oncor" Impression plus recalled	Siemens Medical Solutions USA	Device Malfunction	Nationwide
29 Mar 2017	CLASS II	Mevatron M2/Primus Mid-Energy Primus HI recalled	Siemens Medical Solutions USA	Device Malfunction	Nationwide

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

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16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide