Reported Aug 7, 2013 · Terminated
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
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 Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
- Lot codes and dates
Model number 10094200serial numbers 402440774043 and 4051
- Amount recalled
- 4
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
Why it was recalled
Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the floor. Four consignees were notified of this recall by Update Instruction XP067/12/S -- all four units have been corrected.
This product could cause temporary or reversible health problems — stop using it.
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