| qms_version | 2.2.0 |
|---|---|
| sop_id | CSC PR.012 |
| sop_version | 2.0.1 |
| template_id | CSC F.006 |
| template_version | 2.0.1 |
| Template ID | CSC F.006 |
| Template Version | 2.0.1 |
| QMS Version | 2.2.0 |
| SOP ID | CSC PR.012 |
| SOP Version | 2.0.1 |
| Regulatory References |
| Author | |
| Approval |
Specific details to enable the affected product to be easily identified e.g. type of device , Application name and version numbers of affected devices.
Insert or attach list of individual devices. Where possible add a reference to a manufacturers' website e.g. the CSC Project GitHub Repository.
A factual statement explaining the reasons for the Field Safety Corrective Action (FSCA), including description of the device deficiency or malfunction, clarification of the potential hazard associated with the continued use of the device and the associated risk to the patient, user or other person. Any possible risk to patients associated with previous use of affected devices.
Include, as appropriate:
- identifying and quarantining the device
- description of how the application will be updated, or removed from clinical workflows
- timelines
- Confirmation form to be sent back to the manufacturer if an action is required e.g. removal of application from clinical use
This notice needs to be passed on all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred. (If appropriate)
Please transfer this notice to other organisations on which this action has an impact. (If appropriate)
Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. (if appropriate)
{Name / organisation, address, contact details.}
The undersign confirms that this notice has been notified the appropriate Regulatory Agency (Closing paragraph)