Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118 — Class II medical device recall Z-2526-2018
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-08-01, distributed in HI, IL, MI, NC, NY, VA, WI. Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could ca
| Recall number | Z-2526-2018 |
|---|---|
| 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 | 2018-05-25 |
| Classified | 2018-07-20 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2019-05-16 |
| Distributed | HI, IL, MI, NC, NY, VA, WI |
| Quantity | 3 us |
| Reason classes | device malfunction |
Product
Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
Reason for recall
Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure
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-2526-2018. 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.