Reported Sep 28, 2016 · Terminated
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing,…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
- Lot codes and dates
- Serial Numbers
338 of 338 codes
220755101060220807221363220497221053100662130301101494130643101312310364102213221225130653220687220811310395102048100741102523101739221244102125102401310397102036220939100915221110100598130765130321130118310310102477130692102008130159101757101773100751100713101802102535310536221199102089220451101559101479130252100417100421100641100642100644100646100418100419
- Serial Numbers
- Amount recalled
- 338 systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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