Reported Mar 13, 2013 · Terminated
Philips Digital Diagnost Stationary radiographic system
Philips Healthcare 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: Philips Healthcare Inc. · 3000 Minuteman Road · Andover, MA · 01810
Is this the product you have?
- Philips Digital Diagnost Stationary radiographic system
- Lot codes and dates
- All Digital Diagnost systems with Eleva software version 3.0.x
- Amount recalled
- 360
Where it was sold
- Nationwide
Why it was recalled
When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
This product could cause temporary or reversible health problems — stop using it.
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