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