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 | Potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner with a tilted gantry. In a 2x2 layout, the 4D tabcard will show an incorrect, too small length measurement. This could result in selecting a device of the wrong size, which then needs to be exchanged. |
| Product | Software version VD10E for Syngo X-Workplace; Picture archiving and communication system. |
| Quantity | 73 units |
| Distribution | Nationwide Distribution including: AL, AZ, CA, CO, FL, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NC, NY, OH, OK, PA, SC, TN, TX, VA, and WI. |
| Initiated | 2015-11-18 |
| Classified | 2016-01-06 |
| Terminated | 2016-12-05 |
| Recall number | Z-0597-2016 |
| 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-0597-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72751/
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