Azurion 7 M20 (2020-03-03)

Starting date:

March 3, 2020

Posting date:

April 15, 2020

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-72729

Last updated: 2020-04-15

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  Reason
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  Affected products

Affected Products

Azurion 7 M20

Reason

Philips has identified that no torque was specified for the four screws that connect the gearbox and the mounting flange within the c-arm roll motor. If the torque is too low, the movement of the system may lead to stress on the screws, which potentially could result in the four screws becoming loose. If this occurs, the c-arm could rotate freely over the "roll" movement and the system would not be available for use.

Affected products