Recalls / —
—#114464
Product
Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system
- FDA product code
- MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K982795
- Affected lot / code info
- Systems with Eleva SW version 2.1.3
Why it was recalled
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.
Root cause (FDA determination)
Software design
Action the firm took
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.
Recalling firm
- Firm
- Philips Healthcare Inc.
- Address
- 3000 Minuteman Road, Andover, Massachusetts 01810
Distribution
- 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.
Timeline
- Recall initiated
- 2012-10-25
- Posted by FDA
- 2013-02-26
- Terminated
- 2014-03-31
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #114464. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.