Alice 6 PSG System (2018-03-16)

Starting date:

March 16, 2018

Posting date:

May 11, 2018

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-66726

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  Reason
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  Affected products

Affected products

Alice 6 PSG System

Reason

Philips Respironics has identified an issue with the amount of memory installed in the PC provided for use with Sleepware G3 and the Alice 6 PSG system. Impacted PCs are configured with 4GB of installed memory (RAM) instead of the recommended and documented 8GB. The lower amount of RAM can impact the performance of Sleepware G3 software, but will not render the software inoperable or impact the ability to conduct studies or collect data. Installation of a 4GB DIMM card, which will be provided by Philips Respironics, is required to upgrade the system to the intended 8GB configuration.

Affected products