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Terminated

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.

FDA Recall Z-0325-2016 · Posted 2015-11-23

Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeLNH
Date Initiated2014-08-21
Date Terminated2021-05-12
Product Quantity307 units

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.

Firm Action

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

Root Cause

Software Design Change

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110151ACHIEVA R4 1.5T AND ACHIEVA R4 3.0TPhilips Health Care · 2011-03-22K063559ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5Philips Medical Systems · 2007-01-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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