Siemens Syngo Imaging V31 PACS Recall: Potential Data Loss Risk
Siemens recalls Syngo Imaging version V31 (model 10014063) due to potential data loss affecting medical imaging diagnoses. Affected units include specific serial numbers listed in the recall notice.
Lower-risk recall
Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.
Contact the company
What happened, in plain English
Siemens is recalling a specific version of its medical imaging software (Syngo Imaging V31) because it may cause data loss that could impact medical diagnoses. This recall affects hospitals and clinics using the listed serial numbers. Read more at govinfonow.com/recall/73357-siemens-syngo-imaging-v31-pacs-recall-potential-data-loss-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73357-siemens-syngo-imaging-v31-pacs-recall-potential-data-loss-risk · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0405-2018
Cite this page
“Siemens Syngo Imaging V31 PACS Recall: Potential Data Loss Risk.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73357-siemens-syngo-imaging-v31-pacs-recall-potential-data-loss-risk. Based on FDA recall #Z-0405-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0405-2018%22&limit=1).
Why it’s dangerous
The software may cause data loss during medical imaging processes, which could lead to incorrect diagnoses if critical patient images are not properly stored or retrieved. This is a potential issue with the system's data management features.
Who’s affected
Hospitals and clinics using the specific Syngo Imaging V31 version (model 10014063) with the listed serial numbers are affected. Medical staff and patients who rely on this system for imaging diagnoses are at risk.
How to tell if you have this one
Check if your system has the model number 10014063 and the listed serial numbers (1334, 1065, 1417, 1043, 1353, 1491, 1496, 1316, 1279, 1116, 1090, 1081, 1310, 1226, 1396, 1107, 1343, 1198, 1432, 1058, 1082, 1055, 1049, 1329, 1490, 1083, 1053, 1079, 1218, 1451, 1386, 1064, 1500, 1005, 1322, 1074).
- Brand
Siemens- Category
Medical device
What to do — step by step
Check Your Serial Number
Verify if your system has the model number 10014063 and one of the listed serial numbers.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 21 states.
FDA distribution: “USA (nationwide) Distribution to the states of: MA, CA, NC, WI, NY, NE, PA, AL, NJ, MO, MI, TX, MS, KS, LA, CT, MD, LA, CO, OK, MN and TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, Connecticut, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Wisconsin.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0405-2018 (July 25, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0405-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.