Reported Apr 27, 2022 · Ongoing
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures
- Model11327700
- Lot codes and dates
- S/NSerial
170319170026170343170367170368170305170360170307170331170349170309170310170361170351170383170023170304170328170334170336170025170346170051170358170357170333170365170332170312170027170303170378170322170053170364
- UDI04056869149325
- S/NSerial
- Amount recalled
- 35 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Siemens Medical Solutions USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.