Reported Jun 3, 2015 · Terminated
SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film…
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 · 19355-1406
Is this the product you have?
- SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations.
- Lot codes and dates
- Model Number
- of device 10762472 with serial numbers
610346105261045610136105461056610216105061053610326101561046610286104061011610296104861060610426103561014610256104361036610386102261037610496104461062610306101861027610616103361039610476103161041610556101961057610596101761051
- Amount recalled
- 133 total
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.
This product could cause temporary or reversible health problems — stop using it.
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