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Philips Medical Systems, Inc. recalls Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View softw
Recalled December 2, 2015 · FDA recall Z-0325-2016 · Philips Medical Systems
Hazard
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. · FDA Class II
Units
307 units
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Philips Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →