CLASS II ONGOING Device recall · Reported 10 Jul 2024 · FDA Enforcement Report
Artis is a family of dedicated angiography systems recalled
Siemens AG/Siemens Healthcare is recalling Artis is a family of dedicated angiography systems developed for single and biplane, distributed nationwide in the US. The recall was initiated on 26 Jun 2024 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-2242-2024
- FDA event ID
- 94892
- Recalling firm
- Siemens AG/Siemens Healthcare, Forchheim, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jun 2024
- FDA classified
- 2 Jul 2024
- Reported
- 10 Jul 2024
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 26 Jun 2024 | Recall initiated by company | |
| 2 Jul 2024 | Classified by FDA | +6 days |
| 10 Jul 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.
Product as listed by the FDA
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
Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC.
Nationwide IllinoisMassachusettsMichiganMinnesotaMissouriNorth CarolinaNew HampshireNew JerseyNew YorkOklahomaSouth CarolinaTexas
Questions about this recall
Why was it recalled?
A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.
Which lots are affected?
ARTIS icono biplane 11327600 4056869063317 ARTIS icono ceiling 11328100 4056869295923 ARTIS icono floor 11327700 4056869149325
Where was it sold?
Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC.
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
2 other products · FDA event 94892This product is part of a recall event; the main page for the event is Artis is a family of dedicated angiography systems recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Artis is a family of dedicated angiography systems recalled | Siemens AG/Siemens Healthcare | Other | Nationwide | |
| CLASS II | Artis is a family of dedicated angiography systems recalled | Siemens AG/Siemens Healthcare | Other | Nationwide |
More recalls from Siemens AG/Siemens Healthcare
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Artis is a family of dedicated angiography systems recalled | Siemens AG/Siemens Healthcare | Other | Nationwide |
| Device | CLASS II | Artis is a family of dedicated angiography systems recalled | Siemens AG/Siemens Healthcare | Other | Nationwide |
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| 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 |