CLASS II Device recall · Reported 4 Jul 2018 · FDA Enforcement Report
Artis zee biplane MN, Material no. recalled
Siemens Medical Solutions USA is recalling Artis zee biplane MN, Material no. 10094143, 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
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-2309-2018
- 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 zee biplane MN, Material no. 10094143, 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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
10094143 10094143
Where was it sold?
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.
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
11 other products · FDA event 80286This product is part of a recall event; the main page for the event is Artis Q.zen floor, Material no. recalled.
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