Elekta UNITY (2019-06-12)

Starting date:

June 12, 2019

Posting date:

July 19, 2019

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-70437

Last updated: 2019-07-19

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  Reason
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  Affected products

Affected Products

Elekta UNITY

Reason

If the Set To Work (STW) phase 2 of the installation is not conducted in the correct order, the MR to MV offset values cannot be exported to the EQ database at STW phase 2 and (0,0,0) values are set instead by software installer in order to run clinical workflow tests.

Affected products