Class II — Siemens Medical Solutions USA, Inc
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the gantry system. |
| Product | AXIOM Artis Systems Product usage: Artis zee 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. |
| Quantity | 37 |
| Distribution | USA Nationwide Distribution in the states of WI, KY, OH, NJ, NC, FL, PA, MA, IA, TX, NY, IL, MI, AZ, CA, and LA. |
| Initiated | 2014-02-07 |
| Classified | 2014-03-21 |
| Terminated | 2014-12-30 |
| Recall number | Z-1272-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc (Z-1272-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67556/
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