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 | There were multiple issues identified in the system software which required an update. |
| Product | Atellica IM 1600 Analyzer, Material Number 11066000 |
| Quantity | 366 |
| Distribution | The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY, and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark,… |
| Initiated | 2019-03-07 |
| Classified | 2019-05-09 |
| Terminated | 2020-08-20 |
| Recall number | Z-1300-2019 |
| 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-1300-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82602/
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