CLASS II Device recall · Reported 28 Mar 2018 · FDA Enforcement Report
Axiom Artis angiographic x-ray system recalled
Siemens Medical Solutions USA is recalling Axiom Artis angiographic x-ray system, distributed in 12 states. The recall was initiated on 5 Jan 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-1150-2018
- FDA event ID
- 79540
- Recalling firm
- Siemens Medical Solutions USA, Malvern, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jan 2018
- FDA classified
- 21 Mar 2018
- Reported
- 28 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Imaging Equipment
Timeline
| 5 Jan 2018 | Recall initiated by company | |
| 21 Mar 2018 | Classified by FDA | +75 days |
| 28 Mar 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
Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is 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.
Where it was distributed
US Distribution in the following U.S. states: AZ, CA, FL, IA, IL, LA, MI, NC, NJ, OH, OK, and TX.
ArizonaCaliforniaFloridaIowaIllinoisLouisianaMichiganNorth CarolinaNew JerseyOhioOklahomaTexas
Questions about this recall
Why was it recalled?
Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Which lots are affected?
Serial Numbers: 35061 35054 34999 35098 35059 35064 35073 35071 35057 35075 35083 35018 35097 35108 35046 35048 35050 46004 35045 35004 44011 35095
Where was it sold?
US Distribution in the following U.S. states: AZ, CA, FL, IA, IL, LA, MI, NC, NJ, OH, OK, and TX.
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.
More recalls from Siemens Medical Solutions USA
All 796| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Artis icono ceiling recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis icono biplane recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis icono floor recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis icono ceiling recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis pheno recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | PA |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |