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Achieva 3.0t mri system-main unit

Official notice

18 Dec 2025

MediumHealth Canada

An official Health Canada notice concerns Achieva 3.0t mri system-main unit. Philips has become aware through in-house testing of a potential safety issue affecting MR systems operating on software versions R11.1 to R12.1 that could pose a risk for patients. Philips has identified potential stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). Published 2025-12-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81380

Official notice

2025-12-18

The hazard

Philips has become aware through in-house testing of a potential safety issue affecting MR systems operating on software versions R11.1 to R12.1 that could pose a risk for patients. Philips has identified potential stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Other

RA RA-81380

Recall Numbers

81380

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Affected products

Product 1

Affected products - Achieva 3.0T MRI System-Main Unit, Lot or serial number - Not applicable., Model or catalogue number - ACHIEVA 3.0T

Product 2

Lot or serial number - Not applicable., Model or catalogue number - ACHIEVA 3.0T

Risk / hazard

Philips has become aware through in-house testing of a potential safety issue affecting MR systems operating on software versions R11.1 to R12.1 that could pose a risk for patients. Philips has identified potential stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Philips.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

81380

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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