CLASS II Device recall · Reported 31 Jul 2019 · FDA Enforcement Report
Artis zee biplane MN recalled by Siemens Medical Solutions USA
Siemens Medical Solutions USA is recalling Artis zee biplane MN, distributed nationwide in the US. The recall was initiated on 12 Jun 2019 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-2033-2019
- FDA event ID
- 83203
- Recalling firm
- Siemens Medical Solutions USA, Malvern, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2019
- FDA classified
- 22 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 12 Jun 2019 | Recall initiated by company | |
| 22 Jul 2019 | Classified by FDA | +40 days |
| 31 Jul 2019 | 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
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
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, Model Number 10094143
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Which lots are affected?
Serial Numbers: 149202 149100 149106
Where was it sold?
US Nationwide 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
22 other products · FDA event 83203This product is part of a recall event; the main page for the event is Axiom Artis dTC recalled by Siemens Medical Solutions USA.
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|---|---|---|---|---|---|
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