Freedom EVO 75, 100, 150, and 200 (2018-11-06)
- Starting date:
- November 6, 2018
- Posting date:
- January 8, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-68700
Affected products
A. Freedom EVO 200
B. Freedom EVO 75
C. Freedom EVO 100
D. Freedom EVO 150
Reason
The affected versions are freedom EVOware 2.5 - 2.7 SP3 under Windows XP and Windows 7, and 2.8 under Windows 7 and Windows l0. Both freedom EVOware standard and EVOware plus are affected, in both limited and extended support configurations. This problem does not exist in earlier or later versions of EVOware.
Starting January 1st 2020 at 00:00 hrs, freedom EVOware will abort a run if any processing errors occur or when freedom EVOware is started in conjunction with touchtools.
- In case of using touchtools: the system is not able to start a run
- In case of using EVOware: the system will abort a run when an error message appears and not restart both cases lead to a loss of instrument functionality. There is no risk of safety to operators or of incorrect processing of samples as the script or process stops with error messages.
Affected products
A. Freedom EVO 200
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
10641200
10641202
10641541
30020020
Companies
- Manufacturer
-
Tecan Schweiz AG
Seestrasse 103
Mannedorf
8708
SWITZERLAND
B. Freedom EVO 75
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
20738668
30025019
Companies
- Manufacturer
-
Tecan Schweiz AG
Seestrasse 103
Mannedorf
8708
SWITZERLAND
C. Freedom EVO 100
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
10641100
30020010
Companies
- Manufacturer
-
Tecan Schweiz AG
Seestrasse 103
Mannedorf
8708
SWITZERLAND
D. Freedom EVO 150
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
10641150
10641441
30020015
30087806
Companies
- Manufacturer
-
Tecan Schweiz AG
Seestrasse 103
Mannedorf
8708
SWITZERLAND