REMISOL ADVANCE (2021-03-22)
- Starting date:
- March 22, 2021
- Posting date:
- April 1, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-75299
Last updated:
2021-04-01
Affected Products
REMISOL ADVANCE
Reason
Instructions For Use for versions 1.5 to 1.9 do not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that were not validated or incorrectly validated may lead to erroneous results.
Affected products
REMISOL ADVANCE
Lot or serial number
- More than 10 numbers, contact manufacturer.
Model or catalog number
- VERSION 1.5
- VERSION 1.6
- VERSION 1.7
- VERSION 1.8
- VERSION 1.9
Companies
- Manufacturer
-
Normand - Info Sasu
7 rue Frederic Degeorge
Arras Cedex
62028
FRANCE