Cios Alpha & Cios Fusion (2020-03-06)

Starting date:

March 6, 2020

Posting date:

April 15, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72737

Last updated: 2020-04-15

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  Reason
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  Affected products

Affected Products

1. Cios Alpha
2. Cios Fusion

Reason

This update provides software version VA20G which resolves the following issues and prevents them from recurring. The update is not providing new features or new functionality. These fixes do not affect patient safety.

• SW bugs regarding total dose and acquisition time lost on dose report.
• Introduction of additional units for DAP display (local requirement in switzerland).
• Solid core to react regarding cyber security issues.
• Data privacy issue solved.
• Microsoft hotfixes.

Affected products