| | Class 2 Recall
Philips Digital Diagnost |  |
| Date Posted |
February 26, 2013 |
| Recall Number |
Z-0884-2013 |
| Product |
Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3
Model numbers 712020, 712022, and 712082
Product Usage:
Digital radiographic system |
| Code Information |
Systems with Eleva SW version 2.1.3
|
Recalling Firm/
Manufacturer |
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810 |
| Consumer Instructions |
No consumer action necessary |
| For Additional Information Contact |
Beth St. Germain
978-659-4519
|
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.
|
| 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. |
| Quantity in Commerce |
551 |
| Distribution |
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. |
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