Reported Jun 17, 2020 · Terminated
Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows
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
Is this the product you have?
Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows
5 of 5 products
| Model / number | Product as published |
|---|---|
10848280 | Artis Q floor |
10848281 | Artis Q ceiling |
10848282 | Artis Q biplane |
10094137 | Artis zee ceiling |
10094135 | Artis zee floor Product Usage: Artis is a family of 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
- Serial NumbersSerial
125253103340121526121521103335109621138311148418147237109620136555121520121525121518125254
- Serial NumbersSerial
- Amount recalled
- 15 US
Where it was sold
- Nationwide
Why it was recalled
Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interruption of electrical contact, and result in planned procedures to be terminated and performed on an alternative x-ray system
This product could cause temporary or reversible health problems — stop using it.
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