Aptio Automation Modules — Class II medical device recall Z-0590-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-11-23, distributed nationwide. Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems.
| Recall number | Z-0590-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2016-09-29 |
| Classified | 2016-11-16 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2018-09-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BD, BE, BH, BR, CA, CH, CN, CZ, DE, DK, EG, ES, GB, GR, ID, IT, KR, LB, MY, PH, PT, QA, SA, SE, TR, TW, VN |
| Quantity | 448 units |
| Reason classes | device malfunction |
Product
Aptio Automation Modules
Reason for recall
Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems.
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-0590-2017. 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.