Philips Healthcare Inc.: Medical Device Recall in 2013 - (Recall #: Z-0884-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 25, 2012

Date Posted: March 6, 2013

Recall Number: Z-0884-2013

Event ID: 63674

Reason for Recall:

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.

Status: Terminated

Product Quantity: 551

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.

Voluntary or Mandated:

Voluntary: Firm initiated