Health product recall

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

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

Elekta  UNITY

Lot or serial number

All lots.

Model or catalog number

1536549

Companies
Manufacturer
Elekta Limited
Linac House, Fleming Way
Crawley, Sussex
RH10 9RR
UNITED KINGDOM