Philips Healthcare Inc.: Medical Device Recall in 2013 - (Recall #: Z-0900-2013)

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 Digital Diagnost Stationary radiographic system

Product Classification:

Class II

Date Initiated: October 30, 2012

Date Posted: March 13, 2013

Recall Number: Z-0900-2013

Event ID: 63671

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: 360

Code Information:

All Digital Diagnost systems with Eleva software version 3.0.x

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Canada, Chile, Czech republic, Estonia,France, Germany, Hungary, Inida, Ireland, Italy, Japan, Libyan Arab Jamahari, Mexico, Netherlands, New Zealand, Norway , Oman, Panama, Peru, Poland, Qatar, Reunion, Russia, Saudi Arabia, South Africa, South Korea,Spain, Sweden, Swizerland, Thailand, UAE, and the UK.

Voluntary or Mandated:

Voluntary: Firm initiated