Reported Aug 26, 2015 · Terminated
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and…
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?
- Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Lot codes and dates
- Model Numbers of device
10094135100941371009413910094141100941421009414310280959
- with serial numbers
586 of 586 codes
146669153131153229146877157435146663147100147049147233136077147189147190153695157660153727157458146335146659153779146993153280153648153674160395160484135757136513136562147273157698147030147239146988160348157532160502146899135102153169146643136042153803146361146365146366146369146116146164146168153110160392147371160115135986157690154074154012147129135841153732
- Model Numbers of device
- Amount recalled
- 586
Where it was sold
- Nationwide
Why it was recalled
in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray locking function is active, the only way to exit the X-ray locking function, would be to either resolve the root cause of the system being in "Bypass Fluoro" or to restart the system.
This product could cause temporary or reversible health problems — stop using it.
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