Class II — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | |
| Product | FlexLab Automation Modules |
| Quantity | 448 units |
| Distribution | Distributed Nationwide and to the following countries: Australia, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Canada, Czech Republic, Denmark, Egypt, Germany, Greece, Indonesia, Italy, Kingdom Saudi Arabia, Lebanon, Malaysia, P.R. China, Philippines, Portugal, Qatar, Republic Korea, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United Kingdom, Vietnam |
| Initiated | 2016-09-29 |
| Classified | 2016-11-16 |
| Terminated | 2018-09-19 |
| Recall number | Z-0591-2017 |
| 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 Healthcare Diagnostics, Inc. (Z-0591-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75417/
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