CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report
Artis zee/zeego, Angiographic x-ray system Stand alone recalled
Siemens Medical Solutions USA is recalling Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a, distributed nationwide in the US. The recall was initiated on 8 Dec 2016 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-0971-2017
- FDA event ID
- 76016
- Recalling firm
- Siemens Medical Solutions USA, Malvern, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Dec 2016
- FDA classified
- 9 Jan 2017
- Reported
- 18 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 8 Dec 2016 | Recall initiated by company | |
| 9 Jan 2017 | Classified by FDA | +32 days |
| 18 Jan 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
Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.
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/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee/ zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.
Which lots are affected?
Model # 10094135, 10094137, 10094139, 10094141, 10280959, 10848283
Where was it sold?
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
1 other product · FDA event 76016| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Artis Q/Q.zen, Angiographic x-ray system Stand alone system recalled | Siemens Medical Solutions USA | Device Malfunction | Nationwide |
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