Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.
This recall has been terminated (originally issued November 23, 2015).
- Company
- Philips Medical Systems, Inc.
- Recall Initiated
- August 21, 2014
- Posted
- November 23, 2015
- Terminated
- May 12, 2021
- Recall Number
- Z-0325-2016
- Quantity
- 307 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultant image order is reversed. This occurs with software release R5.1.7/R5.1.8.
Distribution
Worldwide Distribution - USA (nationwide) and to the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Denmark Estonia, Ethiopia. France, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Korea, Republic of, Libya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Palestinian territory, Peru, Poland, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates and United Kingdom.
Lot / Code Info
Software versions R5.1.7 and R5.1.8
Root Cause
Software Design Change
Action Taken
Philips Healthcare sent an Customer Information Letter dated July 2014, on August 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips will issue a Field Change Order to install updated software in a Service Pack that makes the slice numbering consistent for fused and unfused images. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377