ClearCanvas Workstation and ClearCanvas Web Station (2020-02-26)
- Starting date:
- February 26, 2020
- Posting date:
- April 16, 2020
- 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-72755
Last updated: 2020-04-16
Affected Products
- ClearCanvas Workstation
- ClearCanvas Web Station
Reason
A software defect was discovered when investigating a customer complaint submitted on 2020-02-04. While the likelihood of potential serious health consequences is remote, the use of the defective software associated could result in misdiagnosis, potentially causing significant indirect harm necessitating medical intervention that is serious but temporary
Affected products
A. ClearCanvas Workstation
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
Synaptive Medical Inc.
555 Richmond Street West, Suite 800
Toronto
M5V 3B1
Ontario
CANADA
B. ClearCanvas Web Station
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
Synaptive Medical Inc.
555 Richmond Street West, Suite 800
Toronto
M5V 3B1
Ontario
CANADA