The Recall Desk
ModerateFDA (Devices)·Z-0325-2016·Announced 2015-12-02

Philips MRI Systems Recalled for Reversed Image Order in MobiView Software

Philips is recalling specific MRI systems with MobiView software due to a defect that reverses the order of fused multi-station scan images.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a software error in image ordering without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Philips Medical Systems, Inc. is recalling 307 units of Ingenia, Intera, Achieva, and Achieve dStream MR systems. The affected units are running software versions R5.1.7 and R5.1.8 with the Mobi View software option. These diagnostic imaging systems were distributed nationwide in the United States and in numerous countries worldwide.

The recall is due to a software defect where the order of images is reversed when a fused series of a sagittal, coronal, or radial multi-station scan is generated in MobiView. This issue occurs specifically with software releases R5.1.7 and R5.1.8.

Healthcare facilities and users of these systems should contact Philips Medical Systems for further instructions on how to resolve the software issue.

The recalled product

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.
Affected units
307

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Software versions R5.1.7 and R5.1.8

Distribution

Distributed nationwide across the United States.