VeriQ and VeriQ C System (2018-05-04)
- Starting date:
- May 4, 2018
- Posting date:
- June 1, 2018
- 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-66938
Affected products
A. VeriQ System
B. VeriQ C System
Reason
This communication from Medistim was issued due to the possibility that flow measurement channels on Medistim systems can operate with a significant zero-point offset value, caused by Electrostatic Discharge (ESD). Medistim has therefore further issued updated Instructions For Use (IFU) which clarifies and emphasizes the importance of routinely performing the probe and system functionality test prior to use in order to ensure that the system and probes function appropriately. There is no product retrieval associated with this field safety notice. This is a notification only, pertaining to the updated IFU.
Affected products
A. VeriQ System
Lot or serial number
All lots.
Model or catalog number
VQ4122
Companies
- Manufacturer
-
Medistim ASA
Økernveien 94, Oslo
0579
NORWAY
B. VeriQ C System
Lot or serial number
All lots.
Model or catalog number
VQ4122C
Companies
- Manufacturer
-
Medistim ASA
Økernveien 94, Oslo
0579
NORWAY