Reported Jul 2, 2014 · Terminated
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of…
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 · 51 Valley Stream Pkwy · Malvern, PA · 19355
Is this the product you have?
- Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
- Lot codes and dates
- Material nos.: 4503178, 5493072, and 8148178 with serial nos.:
108 of 108 codes
93-069593-069393-093893-101093-073093-045493-075993-084893-088493-115893-058493-003793-105393-072693-058893-061493-056693-103893-064893-080393-081393-138793-027893-085693-031493-065793-022293-143893-066293-077993-073293-084193-104593-048793-056493-057793-079293-023193-009693-084693-057493-066893-063493-088793-114593-081893-010293-076493-050193-049093-026193-057093-073993-113393-015993-087293-153193-066093-079893-0528
- Material nos.: 4503178, 5493072, and 8148178 with serial nos.:
- Amount recalled
- 108
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
There is a potential risk when using LANTIS OIS System client software with operating systems for which it has not been validated and released, resulting in incorrectly stored data, such as treatment records, and LANTIS database corruption.
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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