Reported Sep 26, 2018 · Terminated
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
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?
- ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
- Lot codes and dates
- 164013 164011
- Amount recalled
- 429 total
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
Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).
This product could cause temporary or reversible health problems — stop using it.
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