SOKINOX NO DELIVERING AND MONITORING SYSTEM (2021-05-17)
- Starting date:
- May 17, 2021
- Posting date:
- May 26, 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-75667
Last updated:
2021-05-26
Affected Products
SOKINOX NO DELIVERING AND MONITORING SYSTEM
Reason
The manufacturer received a limited number of user reports with "Flow sensor line blocked" alarm, when the problem is in the flow sensor board. The customer can in conventional ventilation use the backup system but if they are in HFOV therapy that option is not available. All customers shall be informed of this issue and instructed in how to act if this occur via the enclosed Customer Letter.
Affected products
SOKINOX NO DELIVERING AND MONITORING SYSTEM
Lot or serial number
- More than 10 numbers, contact manufacturer.
Model or catalog number
- 6694550
Companies
- Manufacturer
-
Maquet Critical Care AB
Rontgenvagen 2
Solna
17154
SWEDEN