Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use: Stationary radiographic system, Radiographic system, digital
This recall has been terminated (originally issued April 26, 2012).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- April 3, 2012
- Posted
- April 26, 2012
- Terminated
- March 13, 2014
- Recall Number
- Z-1464-2012
- Quantity
- 606 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential misdiagnosis due to improperly automatically stitched images, improper image ruler handling.
Distribution
Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech. Rep, Denmark, Finland, France, Germany, Guadeloupe, India, Indonesia, Iran, Iraq, Italy, Japan, Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Salkowski, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Ver.Arab.Emir.
Lot / Code Info
Model #s 712020, 712022, 712082 All systems with Eleva software version 2.x and stitching option.
Root Cause
Labeling design
Action Taken
The firm, Philips Healthcare Imaging, issued an "URGENT-FIELD SAFETY NOTICE" dated March 30, 2012 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions carefully and to not use the Philips Image Ruler for measurements. The firm plans to supply an Addendum to the Instructions For Use and a Philips Service Engineer will contact the customer as soon as the Field Action Kit is ready to be implemented. If you need any further information or support concerning this issue, please contact your local Philips representative or call 1-866-767-2822.