Reported Mar 6, 2013 · Terminated
Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage:…
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 DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022
- and 712082 Product UsageDigital radiographic system
- Lot codes and dates
- Systems with Eleva SW version 2.1.3
- Amount recalled
- 551
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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