Achieva and Intera 1.5T MRI System - Main Unit (2018-03-22)

Starting date:

March 22, 2018

Posting date:

April 13, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-66402

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  Reason
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  Affected products

Affected products

Reason

In rare cases, helium gas may escape into the examination room when superconductivity is lost (also known as quenching of the magnet) and at the same time the designed helium ventilation path is impeded. Philips has become aware of one instance where this happened in a Philips system. Investigation found the metal burst disk assembly in the vent path did not perform according to specifications.

Affected products