AXIOM Artis Systems Product usage: Artis zee is a family of dedicated… — Class II medical device recall Z-1272-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-04-02, distributed nationwide. Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors
| Recall number | Z-1272-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2014-02-07 |
| Classified | 2014-03-21 |
| Reported by FDA | 2014-04-02 |
| Terminated | 2014-12-30 |
| Distributed | Nationwide (US) |
| Quantity | 37 |
| Reason classes | packaging |
| Serial numbers | 34999, 35004, 35008, 35014, 35018, 35019, 35020, 35042, 35044, 35045, 35046, 35048, 35050, 35053, 35054, 35055, 35056, 35057, 35061, 35064, 35069, 35073, 35097, 35098, 35108 and 12 more |
| Model numbers | 7412807, 7727717, 7728392 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1272-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.