Health product recall

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

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

Infinity Central Station

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

MS 18500

Companies
Manufacturer

Draeger Medical Systems, Inc.

3135 Quarry Road

Telford

18969

Pennsylvania

UNITED STATES