Class II — Siemens Medical Solutions USA, Inc
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging. |
| Product | A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. |
| Quantity | 49 imaging systems |
| Distribution | US (nationwide) including the states of AL, CA, CO, CT, FL, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OK, OR, PA, TN, TX, and WI. |
| Initiated | 2016-01-18 |
| Classified | 2016-04-07 |
| Terminated | 2017-08-03 |
| Recall number | Z-1349-2016 |
| 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 Medical Solutions USA, Inc (Z-1349-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73475/
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