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

Recall Insight

This FDA Devices action (record #Z-0884-2013) was formally reported on March 6, 2013, with the manufacturer initiating the action on October 25, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Healthcare Inc. is listed as the recalling firm, operating out of Andover, MA. Federal records indicate 551 units are affected.

The documented reason for this recall is: 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. … Distribution data in the federal record shows the product reached: 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, Switzer…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.