Z-0325-2016Class II

Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi...

Name: Z-0325-2016 Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi...
Creator: Philips Medical Systems, Inc.
Published: 2014-08-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-08-21 / Terminated / root cause: software

FDA source

Philips Medical Systems, Inc. began a recall of 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 on 2014-08-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0325-2016
Classification: Class II
Status: Terminated
Initiated: 2014-08-21
Posted: 2015-11-23
Terminated: 2021-05-12
Recalling firm: Philips North America LLC
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.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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.
Root cause tag: software
FDA root cause: Software Design Change
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
Quantity in commerce: 307 units
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.
Product codes and lots: Software versions R5.1.7 and R5.1.8

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0325-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0325-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-23

Product code LNH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)