AXIOM Sensis — Class II medical device recall Z-2156-2017
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2017-05-31, distributed nationwide. An extremely dusty computer can cause problems at system start, or rarely, cause system fail. Perform a system
| Recall number | Z-2156-2017 |
|---|---|
| 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 | 2017-04-12 |
| Classified | 2017-05-23 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2018-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 4,095 |
| Serial numbers | 100005, 100006, 100014, 100015, 100016, 100017, 100018, 100036, 20000, 20001, 20002, 20004, 20006, 20014, 20015, 20016, 20017, 20020, 20021, 20023, 20026, 20030, 20033, 20045, 20046 and 475 more |
| Model numbers | 10764561, 11007641, 6623974, 6634633, 6634641, 6634658 |
Product
AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
Reason for recall
An extremely dusty computer can cause problems at system start, or rarely, cause system fail. Perform a system check prior to performing exams. If the Sensis system fails, its functions can not be used. Clinical treatment may need to be terminated, restarted, or transferred to a functioning 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-2156-2017. 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.