Infinity Central Station (2020-01-07)

Starting date:

January 7, 2020

Posting date:

February 7, 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-72257

Last updated: 2020-02-07

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  Reason
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  Affected products

Affected Products

Infinity Central Station

Reason

Draeger received 16 complaints reporting a gray screen that intermittently appears when selecting the full disclosure feature utilizing the trending data function on the Infinity Central Sttation (ICS); patient monitoring continues as the user is able to exit the full disclosure feature, to restore the full disclosure functionality, a controlled reboot must be performed to ensure all patients are properly monitored during the reboot. Internal investigation confirmed a software defect manifested in version VG2.1.2.

Affected products