Philips Medical Systems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0325-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 21, 2014

Date Posted: December 2, 2015

Recall Number: Z-0325-2016

Event ID: 69127

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.

Status: Terminated

Product Quantity: 307 units

Code Information:

Software versions R5.1.7 and R5.1.8

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated