Health product recall

Philips Ingenia, Achieva and Intera MR Systems

Last updated

Summary

Product
Philips Ingenia, Achieva and Intera MR Systems
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additionl information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Ingenia 1.5T

Not applicable.

781315

Ingenia 1.5T

Not applicable.

1.5T

Ingenia 3.0T CX

Not applicable.

781271

Achieva 1.5T MRI System - Main Unit

Not applicable.

ACHIEVA 1.5T

Achieva 3.0T MRI System - Main Unit

Not applicable.

ACHIEVA 3.0T

Ingenia Ambition S

Not applicable.

782108

Ingenia Ambition S

Not applicable.

782139

Ingenia 3.0T

Not applicable.

3.0T

Ingenia Ambition X

Not applicable.

782109

Ingenia Ambition X

Not applicable.

781356

Ingenia Ambition X

Not applicable.

782138

Ingenia Elition X

Not applicable.

782107

Ingenia Elition X

Not applicable.

781358

Intera 1.5T MRI System - Main Unit

Not applicable.

INTERA 1.5T

Issue

Philips has become aware of a software issue affecting Philips Magnetic Resonance (MR) imaging systems operating with software versions R5 & R11, which may terminate an examination during the image reconstruction process. If the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory, the system will freeze, preventing image generation and requiring a system re-start.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Philips Medical Systems Nederland B.V.
Veenpluis 6, Best, Netherlands, 5684 PC
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82609

Get notified

Receive emails about new and updated recall and safety alerts.

Subscribe