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Recall Observatory FDA recall evidence

Device product

Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system

Z-0884-2013

October 25, 2012

Class II

Product summary

Firm
Philips Healthcare Inc.
Event
Event 63674
Status
Terminated
Classification
Class II
Quantity
551
Official record key
device-enforcement:Z-0884-2013

Official wording

Reason: 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.

Code information: Systems with Eleva SW version 2.1.3

Distribution pattern: Worldwide Distribution - USA Nationwide and the Foreign countries of: Austria, Canada, Belgium, China,Denmark, France, germany, Italy, Netherlands,New Zealand, Norway, Philippines, Portugual, SOuth Korea, Spain, Switzerland, Thailand, and UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.