CLASS II Device recall · Reported 4 Jul 2018 · FDA Enforcement Report

Artis Q ceiling, Material no. 10848281, for angiography recalled

Siemens Medical Solutions USA is recalling Artis Q ceiling, Material no. 10848281, for angiography and whole body, distributed nationwide in the US. The recall was initiated on 1 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes109011 109009 109007 109020 109010

Quantity recalled5

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-2304-2018
FDA event ID: 80286
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 1 May 2018
FDA classified: 27 Jun 2018
Reported: 4 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

1 May 2018	Recall initiated by company
27 Jun 2018	Classified by FDA	+57 days
4 Jul 2018	Published in enforcement report	+7 days

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

Reason for recall

After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.

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

Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures.

Where it was distributed

Worldwide distribution. US nationwide including Puerto Rico, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Myanmar, Netherlands, New Zealand, Norway, China, Paraguay, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.

Nationwide Puerto Rico

Questions about this recall

Is Artis Q ceiling, Material no. 10848281, for angiography and whole body recalled?

Yes. Siemens Medical Solutions USA recalled Artis Q ceiling, Material no. 10848281, for angiography and whole body on 1 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2304-2018.

Why was it recalled?

Which lots are affected?

109011 109009 109007 109020 109010

Where was it sold?

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
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