Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system
FDA Recall Z-0884-2013 · Posted 2013-02-26
Advertisement
Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeMQB
Date Initiated2012-10-25
Date Terminated2014-03-31
Product Quantity551
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.
Firm Action
Philips Medical Systems issued on October 25, 2012 an Urgent Field Safety Notice for the Digital Diagnost System informing consignees of the software upgrade. The UFSN described the problem, the hazard involved, the action to be taken by the consumer/user and the action planned by Philips. For questions contact your local Philips representative: Technical Support Line 1-800-722-9377.
Root Cause
Software design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement